View Financial HealthThis company listing is no longer activeThis company may still be operating, however this listing is no longer active. Find out why through their latest events.See Latest EventsNuheara 配当と自社株買い配当金 基準チェック /06Nuheara配当金を支払った記録がありません。主要情報n/a配当利回り-52.3%バイバック利回り総株主利回り-52.3%将来の配当利回りn/a配当成長n/a次回配当支払日n/a配当落ち日n/a一株当たり配当金n/a配当性向n/a最近の配当と自社株買いの更新更新なしすべての更新を表示Recent updatesお知らせ • Apr 10Nuheara Limited has completed a Follow-on Equity Offering in the amount of AUD 1.850332 million.Nuheara Limited has completed a Follow-on Equity Offering in the amount of AUD 1.850332 million. Security Name: Ordinary Shares Security Type: Common Stock Securities Offered: 30,838,873 Price\Range: AUD 0.06 Security Features: Attached Options Transaction Features: Subsequent Direct Listingお知らせ • Nov 22Nuheara Limited Announces the Retirement of David Cannington as Non-Executive DirectorNuheara Limited announced that Non-executive Director and co-founder Mr. David Cannington has announced his decision to retire from the Nuheara Board of Directors. As a co-founder of the company and having previously stepped down from executive duties in March 2022, David now concludes his service on the Board.お知らせ • Nov 09Nuheara Limited has completed a Follow-on Equity Offering in the amount of AUD 3.929624 million.Nuheara Limited has completed a Follow-on Equity Offering in the amount of AUD 3.929624 million. Security Name: Ordinary Shares Security Type: Common Stock Securities Offered: 3,846,154 Price\Range: AUD 0.13 Discount Per Security: AUD 0.0039 Security Name: Ordinary Shares Security Type: Common Stock Securities Offered: 19,458,649 Price\Range: AUD 0.13 Discount Per Security: AUD 0.0039 Security Name: Ordinary Shares Security Type: Common Stock Securities Offered: 6,923,077 Price\Range: AUD 0.13 Discount Per Security: AUD 0.0039 Transaction Features: Rights OfferingNew Risk • Oct 19New major risk - Shareholder dilutionThe company's shareholders have been substantially diluted in the past year. Increase in shares outstanding: 62% This is considered a major risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-AU$10m free cash flow). Earnings have declined by 12% per year over the past 5 years. Shareholders have been substantially diluted in the past year (62% increase in shares outstanding). Minor Risks Revenue is less than US$5m (AU$1.9m revenue, or US$1.2m). Market cap is less than US$100m (AU$30.1m market cap, or US$19.0m).分析記事 • Oct 09Does Nuheara (ASX:NUH) Have A Healthy Balance Sheet?David Iben put it well when he said, 'Volatility is not a risk we care about. What we care about is avoiding the...Reported Earnings • Oct 03Full year 2023 earnings released: AU$0.084 loss per share (vs AU$0.16 loss in FY 2022)Full year 2023 results: AU$0.084 loss per share (improved from AU$0.16 loss in FY 2022). Revenue: AU$1.93m (down 50% from FY 2022). Net loss: AU$12.6m (loss narrowed 15% from FY 2022). Over the last 3 years on average, earnings per share has increased by 15% per year but the company’s share price has fallen by 48% per year, which means it is significantly lagging earnings.お知らせ • Sep 15Nuheara Limited, Annual General Meeting, Nov 22, 2023Nuheara Limited, Annual General Meeting, Nov 22, 2023, at 09:00 W. Australia Standard Time. Location: Anzac Club, 28 St Georges Terrace, Perth WA AustraliaNew Risk • Aug 30New major risk - Financial positionThe company has less than a year of cash runway based on its current free cash flow trend. Free cash flow: -AU$10m This is considered a major risk. With less than a year's worth of cash, the company will need to raise capital or take on debt unless its cash flows improve. This would dilute existing shareholders or increase balance sheet risk. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-AU$10m free cash flow). Earnings have declined by 10% per year over the past 5 years. Shareholders have been substantially diluted in the past year (56% increase in shares outstanding). Minor Risks Revenue is less than US$5m (AU$1.9m revenue, or US$1.2m). Market cap is less than US$100m (AU$34.6m market cap, or US$22.4m).お知らせ • Jul 18Nuheara Limited Announces Appointment of Catherine Morgan as Head of Compliance, Regulatory and LegalNuheara Limited announced the key Executive appointment of Catherine Morgan as the Head of Compliance, Regulatory and Legal. This appointment completes Nuheara's global restructure announced 28 April 2023 and cements the Company's transformation over the past two years into a medical device manufacturer of world-first US FDA- cleared Over The Counter (OTC) Hearing Aids. Catherine joins the Nuheara C-suite with over +20 years of experience in the hearing industry, bringing a deep understanding of the hearing healthcare, medical device industry, global regulatory requirements, and quality standards. In this new role Catherine will be responsible for driving regulatory strategies, ensuring adherence to global regulations and standards, and driving continuous improvement initiatives within quality management systems. They will collaborate closely with cross-functional teams to streamline regulatory submissions, enhance product quality, and foster a culture of continuous improvement in all aspects of regulatory and quality operations. Prior to joining Nuheara, Catherine held senior leadership positions at the National Acoustic Laboratories and more than 14 years with Cochlear Ltd. Catherine has a proven track record of successfully navigating complex regulatory landscapes and implementing strong clinical quality management processes and while fostering a culture of regulatory compliance and quality excellence within the hearing market.New Risk • Jun 17New minor risk - Share price stabilityThe company's share price has been volatile over the past 3 months. It is more volatile than 75% of Australian stocks, typically moving 13% a week. This is considered a minor risk. Share price volatility indicates the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. It also increases the risk of potential losses in the short term as the stock tends to have larger drops in price more frequently than other stocks. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-AU$12m free cash flow). Earnings have declined by 13% per year over the past 5 years. Shareholders have been substantially diluted in the past year (97% increase in shares outstanding). Minor Risks Share price has been volatile over the past 3 months (13% average weekly change). Revenue is less than US$5m (AU$1.7m revenue, or US$1.1m). Market cap is less than US$100m (AU$34.5m market cap, or US$23.7m).お知らせ • Jun 07Nuheara Limited has completed a Follow-on Equity Offering in the amount of AUD 4.4 million.Nuheara Limited has completed a Follow-on Equity Offering in the amount of AUD 4.4 million. Security Name: Ordinary Shares Security Type: Common Stock Securities Offered: 24,275,862 Price\Range: AUD 0.145 Security Name: Ordinary Shares Security Type: Common Stock Securities Offered: 6,068,966 Price\Range: AUD 0.145 Transaction Features: Subsequent Direct ListingReported Earnings • Mar 09First half 2023 earnings released: AU$0.048 loss per share (vs AU$0.065 loss in 1H 2022)First half 2023 results: AU$0.048 loss per share. Revenue: AU$765.6k (down 74% from 1H 2022). Net loss: AU$6.46m (loss widened 7.5% from 1H 2022).Board Change • Feb 01Insufficient new directorsNo new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 8 experienced directors. No highly experienced directors. Independent Non-Executive Chairman Chery Edwardes was the last director to join the board, commencing their role in 2020. The following issues are considered to be risks according to the Simply Wall St Risk Model: Insufficient board refreshment.お知らせ • Jan 04Nuheara Announces Commercial Availability of HP Hearing PRO OTC Hearing AidNuheara announced the commercial availability of its HP Hearing PRO. Consumers can now pre-order the HP Hearing PRO self-fitting, air-conduction, OTC hearing soon be able to purchase the product from any retailer carrying the product including Best Buy and Crutchfield. Nuheara's HP Hearing PRO is the first product cleared through the FDA's 510(k) process for both 874.3325 self-fitting and the 800.30 OTC hearing aid classifications under a new product classification code "QUH". HP Hearing PRO is the first FDA cleared self-fitting OTC hearing aid with Hybrid Active Noise Cancellation. The innovative Ear ID(TM) software-in-medical-device and earbud form factor sets the HP Hearing PRO apart from other devices on the market . The HP Hearing PRO self-fitting OTC hearing aids look nothing like a traditional hearing aid. The HP Hearing PRO self- fitting OTC hearing aid brings together superb medical-grade hearing aid technology with the highly desired features of wireless earbuds into a multifunctional device. Users can enjoy clinically-proven natural sound quality. The HP Hearing PRO provides a lifestyle-friendly hearing aid experience with support for situational use and clinically-proven 30% improved hearing using the Focus directionality feature, adjusted to the user's preferences with a tap of the HP Hearing app. Orders can now be placed from retailers and ecommerce partners throughout the US. The recommended retail price for a pair of HP Hearing PRO hearing aids along with an on-the-go charging case is USD 699.00. Product is expected to ship to customers before the end of calendar Quarter 1, 2023. Built to medical-device standards and meeting all FDA requirements for safety and efficacy, the HP Hearing PRO features Ear ID(TM) self-fitting software and technology powered by Nuheara. The HP Hearing PRO self-fitting OTC hearing aid has been clinically proven to be substantially equivalent to a professionally fit hearing aid. The proprietary Ear ID software tests the wearer's individual hearing thresholds from low frequency to high frequency in each ear, then automatically programs the HP Hearing PRO hearing aids for each ear. This ability for the consumer to self-fit through the HP Hearing application, for iOS and Android platform mobile devices, allows a quick and easy acclimation experience for the consumer. The entire experience takes about 10-15 minutes from unboxing through customization of the user's personalized profile to accommodate their perceived mild-to-moderate hearing loss. In addition to the HP Hearing PRO's capabilities as an OTC hearing aid, this innovative product streams media and phone calls via Bluetooth(R). The Active Noise Cancellation minimizes background noise for an immersive sound experience during phone calls or when streaming music. Additional features include: Hearing app for iOS and Android; Rechargeable built-in Li-ion batteries; Medical-grade USB-C charge case; Battery life is up to 8 hours hearing aid processing per full charge per hearing aid; Clinically-proven natural sound quality. Most importantly, the HP Hearing PRO has been clinically validated through research cometed by the National Acoustic c Laboratories to provide a 30% speech understanding improvement in the presence of noise using the directional microphone feature called Focus. This is a huge benefit for consumers in restaurants or social situations where background noise makes understanding speech difficult. Now, at the touch of the HP Hearing app, a wearer can switch the directional microphone settings to Focus on sounds towards their front, quickly allowing for immediate improvement in speech understanding.お知らせ • Dec 30Nuheara Limited has completed a Follow-on Equity Offering in the amount of AUD 3.025401 million.Nuheara Limited has completed a Follow-on Equity Offering in the amount of AUD 3.025401 million. Security Name: Ordinary Shares Security Type: Common Stock Securities Offered: 16,807,781 Price\Range: AUD 0.18 Discount Per Security: AUD 0.0108 Transaction Features: Subsequent Direct Listingお知らせ • Oct 31Nuheara Limited Receives US FDA Approval and Launches HP Hearing PRONuheara Limited announce a major milestone, receiving US Food and Drug Administration (FDA) clearance for its Self-Fitting OTC Hearing Aid. Nuheara's HP Hearing PRO has been cleared by the FDA for both 874.3325 self- fitting and the 800.30 OTC hearing aid classifications under a new product classification code "QUH". Following the landmark law establishing a regulatory category for over-the-counter (OTC) Hearing Aids in the United States (enacted on 17 October 2022) Nuheara plans to bring to market its first medical device as the HP Hearing PRO under its worldwide Trademark License Agreement for use of HP trademarks on Nuheara's hearing aids, personal sound amplification devices and accessories. ASX Announcement The HP Hearing PRO self-fitting OTC hearing aid brings superb medical grade hearing aid technology combined with highly desired features of wireless ear buds into a multifunctional device that will be sold in the US online and in retail stores, including Best Buy, Crutchfield, Amazon.com, and www.HPHearingPRO.com. Initial orders have been placed from retailers and ecommerce partners for availability throughout the US. The Release Date: 31 OCTOBER 2022 recommended retail price for a pair of HP Hearing PRO hearing aids along with a charge case for on-the-go charging is USD 699.00. The OTC hearing aid rule enactment in the US allows hearing aids within the OTC category, for perceived mild to moderate hearing loss, to be sold directly to consumers in retail stores or online. Access to hearing solutions in retail is something that Nuheara has been developing with its hearable products sales over the past 5 years. As such, the business is well placed to take immediate and significant advantage of the regulation changes.お知らせ • Oct 27Nuheara Limited to Report Q1, 2023 Results on Oct 31, 2022Nuheara Limited announced that they will report Q1, 2023 results on Oct 31, 2022お知らせ • Oct 21+ 1 more updateNuheara Limited Announces the Resignation of Jean-Marie Rudd as CFONuheara Limited announced that Jean-Marie Rudd has exited from her role as CFO, effective immediately. The company will shortly commence a search process for a new CFO to support the Company through its next growth phase.Reported Earnings • Oct 07Full year 2022 earnings released: AU$0.16 loss per share (vs AU$0.10 loss in FY 2021)Full year 2022 results: AU$0.16 loss per share (further deteriorated from AU$0.10 loss in FY 2021). Revenue: AU$3.87m (down 64% from FY 2021). Net loss: AU$14.3m (loss widened 82% from FY 2021). Over the last 3 years on average, earnings per share has increased by 24% per year but the company’s share price has fallen by 35% per year, which means it is significantly lagging earnings.お知らせ • Oct 06Nuheara Limited, Annual General Meeting, Nov 29, 2022Nuheara Limited, Annual General Meeting, Nov 29, 2022, at 09:00 W. Australia Standard Time. Location: head office, 190 Aberdeen Street, Northbridge, Western Australia. Northbridge Western Australia AustraliaReported Earnings • Sep 02Full year 2022 earnings released: AU$0.15 loss per share (vs AU$0.093 loss in FY 2021)Full year 2022 results: AU$0.15 loss per share (down from AU$0.093 loss in FY 2021). Revenue: AU$3.87m (down 64% from FY 2021). Net loss: AU$14.1m (loss widened 96% from FY 2021). Over the last 3 years on average, earnings per share has increased by 25% per year but the company’s share price has fallen by 19% per year, which means it is significantly lagging earnings.お知らせ • Aug 19Nuheara Limited Welcomes US Food and Drug Administration's Final Ruling, Establishing A Regulatory Category for Over-The-Counter (Otc) Hearing Aids in the United StatesNuheara Limited welcomed the US Food and Drug Administration's final ruling, establishing a regulatory category for over-the-counter (OTC) Hearing Aids in the United States. In a world first, and most significantly for Nuheara, the ruling allows hearing aids within the OTC category to be sold directly to consumers in stores or online without a medical exam or fitting by an audiologist. There is now a 60-day enactment period until the commencement of OTC hearing aid consumer retail sales are allowed, anticipated for mid-October 2022. The US FDA received over 1,000 public comment submissions on the proposed rule change. The majority of submissions reflected that American people and healthcare professionals agreed on the significant positive impact that OTC hearing aids could have. The public comments also revealed, as expected, that the dominant hearing aid manufacturers strongly opposed the proposed rule, including using industry-funded "astroturf" campaigns intended to distort public opinion. Despite the incumbent hearing aid manufacturers' efforts to jeopardise such an important ruling, the FDA formally ruled in favourof the OTC category for hearing aids. This historical rule change will forever upend the hearing aid industry and unlock historical barriers to entry for the estimated 38 million Americans who experience some hearing loss. Currently in the US, hearing aids are sold at an average cost of USD 4,726 per pair and can be as much as USD 10,000 or more per pair through licensed audiologist and licensed hearing aid retailers. Now, with the ability for those with perceived mild to moderate hearing loss to purchase OTC, this cost could come down lower than USD 1,000 per pair of hearing aids.分析記事 • Jul 30Here's Why Nuheara (ASX:NUH) Must Use Its Cash WiselyWe can readily understand why investors are attracted to unprofitable companies. For example, biotech and mining...お知らせ • May 09Nuheara Limited Announces Executive ChangesNuheara Limited announced that the appointment of John R. Luna as its US based Chief Executive Officer; Co-founder and former CEO, Justin Miller, remaining as the company's Managing Director. John R. Luna joined Nuheara in May 2021 was and previously served as the Chief Revenue Officer and President Americas. John has a proven track record of successfully leading companies and commercializing medical devices over a 30-year career. In the medical device and hearing aid industry, John served previously as CEO and COO of iHear Medical Inc., Chief Business Development Officer of Eargo, and President and COO of Bernafon (Demant).お知らせ • Apr 28Nuheara Limited has filed an IPO in the amount of AUD 5 million.Nuheara Limited has filed an IPO in the amount of AUD 5 million. Security Name: Ordinary Shares Security Type: Common Stock Securities Offered: 45,454,545 Price\Range: AUD 0.11分析記事 • Apr 13Here's Why Nuheara (ASX:NUH) Must Use Its Cash WiselyWe can readily understand why investors are attracted to unprofitable companies. For example, although...お知らせ • Apr 12Nuheara Submits 510(k) for U.S. FDA ClearanceNuheara Limited has taken the final step in its plans to secure US Food and Drug Administration (FDA) clearance for its self-fitting hearing aid by providing its 510(k) submission to the FDA. This follows completion of Nuheara's successful clinical trial by National Acoustic Laboratories (NAL) in January 2022. The trial successfully validated the effectiveness of the Nuheara self-fitted hearing aids compared to unaided listening across a range of settings and situations. The Nuheara hearing aids are designed to be self-fitted by the user, with a software application interface for both iOS and Android smartphones, intended for direct-to-consumer sale and use without the assistance of a hearing care professional. They are intended for individuals 18 years of age or older with perceived mild to moderate hearing loss, which makes up 85% of the US market. The FDA submission for clearance is the final step of Nuheara's expansion plans into the regulatory approved medical device market, which also aligns with the much-awaited U.S. Over-The-Counter Hearing Aid final rule publication in the Federal Register by the FDA expected for northern hemisphere mid-summer 2022.お知らせ • Feb 16Nuheara Announces Executive ChangesNuheara announced the retirement of Co-founder, David Cannington as Chief Marketing Officer. Mr. Cannington will continue supporting Nuheara as a Non-executive Director. The Board thanks Mr. Cannington for his tireless efforts in helping build the business to this stage and look forward to his continued contribution as a member of the Company's Board. Promotion of Seattle-based John Luna to President Americas alongside his existing role of Chief Revenue Officer, effective immediately. Appointment of Tony Sulsona as VP Sales and Marketing, based in the US and effective immediately. Tony has 30 years' experience building medical and consumer product companies in the US.お知らせ • Feb 01Nuheara Limited Announces Successful Clinical Trial Self-Fitted Hearing AidsNuheara Limited announced that is has successfully concluded its hearing aid clinical trial with the final report received from National Acoustic Laboratories. The clinical trial completes a very complex and important milestone for Nuheara on its pathway to an FDA 510(K) submission and pending entrance into the regulated U.S. hearing aid market segment with world leading hearing aid products. The clinical trial was conducted in Australia using Audiology best practices on participants with normal hearing and those with mild and moderate hearing loss by professional clinical Audiologists and clinical researchers at NAL. The trial successfully validated the hearing benefit of the Nuheara self-fitted hearing aids compared to unaided listening with benefits including Improved speech understanding in noise; Improved ability to follow conversations; Ability to reduce background noise levels; Overall hearing improvement when listening in everyday conversations. In relation to the unaided listening condition, the study data provided evidence of the superiority of Nuheara hearing aids with FOCUS enabled over unaided listening, and of substantial effectiveness of the Ear IDTM self- fitted hearing aid devices in the overall experience of listeners. Furthermore, clinical assessment showed improvement in speech understanding by 30% in noise when the Nuheara hearing aids FOCUS feature was enabled. This outcome is consistent with other studies showing advantages in speech understanding in noise with conventional directional microphones in hearing aids ranging from 25% to 30% improvement, depending on the familiarity to the speech, physical fitting, and design of the hearing aids. The effectiveness data of the Nuheara Ear IDTM self-fitting method was also validated, as Software in a Medical Device (SiMD), through clinical and real-world data demonstrating positive outcomes as compared to the expected NAL-NL2 clinical targets that would be performed by an audiologist fit hearing aid in a clinic.お知らせ • Jan 28Nuheara Limited to Report Q2, 2022 Results on Jan 31, 2022Nuheara Limited announced that they will report Q2, 2022 results on Jan 31, 2022お知らせ • Jan 06Nuheara Clinical Trial and FDA 510(K) Pathway UpdateNuheara Limited provided an update on its clinical trial and pathway to FDA 510(K) submission¹ for the Company's pending entrance into the U.S. hearing aid market, in line with its expansion plans into global medical devices. The Nuheara sponsored clinical trial, conducted by National Acoustics Laboratory (NAL), has been completed with all participants data now collected. NAL is expected to publish the final clinical trial report by the end of January 2022. This is an important milestone on the path to US FDA 510(K) submission and regulatory clearance.分析記事 • Dec 24We Think Nuheara (ASX:NUH) Needs To Drive Business Growth CarefullyJust because a business does not make any money, does not mean that the stock will go down. For example, although...お知らせ • Nov 25Nuheara Limited Provides Update on Clinical Trial and Pathway to FDA 510(K) ApprovalNuheara Limited provided an update on its clinical trial and pathway to FDA 510(K) approval for the Company's clinically tested and regulatory approved hearing aids, in line with its expansion plans into medical devices. Recruitment of candidates for the clinical trial being conducted by National Acoustics Laboratory has now been completed. This is an important milestone on the path to regulatory approval. Of further significance, more than 50% of candidates have now commenced the trial, with the remaining candidates expected to commence within the next week. Nuheara has also engaged NAMSA, the world's only 100% medical device-focused contract research organisation, and a U.S. FDA ASCA-accredited medical device biocompatibility laboratory, to conduct Cytotoxicity, Irritation and Sensitisation testing. The testing was conducted in accordance with ISO standards, to demonstrate biocompatibility of Nuheara's proposed hearing aid devices. In accordance with these standards, the following excellent results were recorded: Cytotoxicity testing was found to meet requirements. Irritation testing outcomes resulted in a Primary Irritation Index of zero. Sensitisation testing showed no evidence of contact sensitisation.分析記事 • Aug 25Is Nuheara (ASX:NUH) In A Good Position To Deliver On Growth Plans?We can readily understand why investors are attracted to unprofitable companies. For example, although...Reported Earnings • Aug 18Full year 2021 earnings released: AU$0.005 loss per share (vs AU$0.011 loss in FY 2020)The company reported a solid full year result with reduced losses, improved revenues and improved control over expenses. Full year 2021 results: Revenue: AU$10.7m (up AU$9.00m from FY 2020). Net loss: AU$7.20m (loss narrowed 38% from FY 2020). Over the last 3 years on average, earnings per share has increased by 15% per year but the company’s share price has fallen by 24% per year, which means it is significantly lagging earnings.お知らせ • Mar 10Nuheara Limited Receives U.S. FDA Registration and Hearing Aid Device ListingNuheara Limited announced that the company has received U.S. Food and Drug Administration establishment registration for a medical device listing of a new hearing aid, IQbuds² PRO. The PRO, alongside IQbuds MAX, will be second product to be derived from the recently developed IQbuds² hardware platform. With software developments currently in train, the PRO has been designed to provide deeper levels of hearing technology sophistication, while delivering higher levels of hearing enhancement and amplification. The PRO is expected to be launched in the US later in the calendar year. The PRO has received FDA classification as a "HEARING AID, AIR CONDUCTION WITH WIRELESS TECHNOLOGY", Device Class 2 510(k) exempt with an OSM product code. As with all hearing aids classified with the OSM product code, the FDA has classified the PRO as 510(k) exempt. This means the PRO can be sold in the U.S. without the need to conduct clinical trials or submit a 510(k) application. The company’s multi-product strategy has been planned to maximise the company's global sales opportunities by offering multiple products that support varying degrees of hearing loss. MAX will continue to meet the needs of those with mild hearing challenges. The PRO is designed to support adults with higher (moderate) levels of hearing loss and will extend Nuheara's Direct-to-Consumer strategy to the global USD 9billion per annum (North America USD 3.37 billion) hearing aid market.Reported Earnings • Feb 24First half 2021 earnings released: AU$0.001 loss per share (vs AU$0.006 loss in 1H 2020)The company reported a solid first half result with reduced losses, improved revenues and improved control over expenses. First half 2021 results: Revenue: AU$6.91m (up 406% from 1H 2020). Net loss: AU$842.2k (loss narrowed 85% from 1H 2020). Over the last 3 years on average, earnings per share has increased by 2% per year but the company’s share price has fallen by 15% per year, which means it is significantly lagging earnings.分析記事 • Jan 14What Can We Make Of Nuheara's (ASX:NUH) CEO Compensation?Justin Miller is the CEO of Nuheara Limited ( ASX:NUH ), and in this article, we analyze the executive's compensation...お知らせ • Jan 08Nuheara Limited has completed a Follow-on Equity Offering in the amount of AUD 11.5 million.Nuheara Limited has completed a Follow-on Equity Offering in the amount of AUD 11.5 million. Security Name: Ordinary Shares Security Type: Common Stock Securities Offered: 287,500,000 Price\Range: AUD 0.04 Discount Per Security: AUD 0.0024 Transaction Features: Subsequent Direct Listingお知らせ • Dec 30+ 1 more updateNuheara Limited announced that it expects to receive AUD 11.5 million in fundingNuheara Limited (ASX:NUH) announced a private placement of 287,500,000 common shares at a price of AUD 0.04 per share for a gross proceeds of AUD 11,500,000 on December 29, 2020. The transaction price of $0.04 represents a 9% discount to the last closing price on 23 December 2021 of $0.044 and an 17% discount to the 15-day VWAP of $0.0483 per Share.お知らせ • Nov 27Nuheara Limited Appoints Warwick Sauer as DirectorNuheara Limited appoints Warwick Sauer as director at its AGM held on 27 November 2020.分析記事 • Nov 22Is Nuheara (ASX:NUH) Using Debt In A Risky Way?The external fund manager backed by Berkshire Hathaway's Charlie Munger, Li Lu, makes no bones about it when he says...お知らせ • Oct 13Nuheara Receives $2 Million Phase II Works with HP IncNuheara Limited announced a phase II extension of the collaboration agreement with HP Inc. On successfully completing a Proof of Concept (POC), Nuheara has now been awarded a $2 million (USD 1.48 million) Phase II Purchase Order (PO) for works associated with the development and engineering of an ear bud variant specific to HP's confidential use case. Phase I was previously awarded for accompanying software services.お知らせ • Aug 29Nuheara Limited announced that it has received fundingNuheara Limited (ASX:NUH) announced a private placement of 1,000,000 shares on August 21, 2020.決済の安定と成長配当データの取得安定した配当: NUHの 1 株当たり配当が過去に安定していたかどうかを判断するにはデータが不十分です。増加する配当: NUHの配当金が増加しているかどうかを判断するにはデータが不十分です。配当利回り対市場Nuheara 配当利回り対市場NUH 配当利回りは市場と比べてどうか？セグメント配当利回り会社 (NUH)n/a市場下位25% (AU)2.8%市場トップ25% (AU)6.9%業界平均 (Tech)0.6%アナリスト予想 (NUH) (最長3年)n/a注目すべき配当: NUHは最近配当金を報告していないため、配当金支払者の下位 25% に対して同社の配当利回りを評価することはできません。高配当: NUHは最近配当金を報告していないため、配当金支払者の上位 25% に対して同社の配当利回りを評価することはできません。株主への利益配当収益カバレッジ: NUHの 配当性向 を計算して配当金の支払いが利益で賄われているかどうかを判断するにはデータが不十分です。株主配当金キャッシュフローカバレッジ: NUHが配当金を報告していないため、配当金の持続可能性を計算できません。高配当企業の発掘7D1Y7D1Y7D1YAU 市場の強力な配当支払い企業。View Management企業分析と財務データの現状データ最終更新日（UTC時間）企業分析2024/05/26 15:08終値2024/02/27 00:00収益2023/06/30年間収益2023/06/30データソース企業分析に使用したデータはS&P Global Market Intelligence LLC のものです。本レポートを作成するための分析モデルでは、以下のデータを使用しています。データは正規化されているため、ソースが利用可能になるまでに時間がかかる場合があります。パッケージデータタイムフレーム米国ソース例会社財務10年損益計算書キャッシュ・フロー計算書貸借対照表SECフォーム10-KSECフォーム10-Qアナリストのコンセンサス予想+プラス3年予想財務アナリストの目標株価アナリストリサーチレポートBlue Matrix市場価格30年株価配当、分割、措置ICEマーケットデータSECフォームS-1所有権10年トップ株主インサイダー取引SECフォーム4SECフォーム13Dマネジメント10年リーダーシップ・チーム取締役会SECフォーム10-KSECフォームDEF 14A主な進展10年会社からのお知らせSECフォーム8-K* 米国証券を対象とした例であり、非米国証券については、同等の規制書式および情報源を使用。特に断りのない限り、すべての財務データは1年ごとの期間に基づいていますが、四半期ごとに更新されます。これは、TTM（Trailing Twelve Month）またはLTM（Last Twelve Month）データとして知られています。詳細はこちら。分析モデルとスノーフレーク本レポートを生成するために使用した分析モデルの詳細は当社のGithubページでご覧いただけます。また、レポートの使用方法に関するガイドやYoutubeのチュートリアルも掲載しています。シンプリー・ウォールストリート分析モデルを設計・構築した世界トップクラスのチームについてご紹介します。業界およびセクターの指標私たちの業界とセクションの指標は、Simply Wall Stによって6時間ごとに計算されます。アナリスト筋Nuheara Limited 0 これらのアナリストのうち、弊社レポートのインプットとして使用した売上高または利益の予想を提出したのは、 。アナリストの投稿は一日中更新されます。0
お知らせ • Apr 10Nuheara Limited has completed a Follow-on Equity Offering in the amount of AUD 1.850332 million.Nuheara Limited has completed a Follow-on Equity Offering in the amount of AUD 1.850332 million. Security Name: Ordinary Shares Security Type: Common Stock Securities Offered: 30,838,873 Price\Range: AUD 0.06 Security Features: Attached Options Transaction Features: Subsequent Direct Listing
お知らせ • Nov 22Nuheara Limited Announces the Retirement of David Cannington as Non-Executive DirectorNuheara Limited announced that Non-executive Director and co-founder Mr. David Cannington has announced his decision to retire from the Nuheara Board of Directors. As a co-founder of the company and having previously stepped down from executive duties in March 2022, David now concludes his service on the Board.
お知らせ • Nov 09Nuheara Limited has completed a Follow-on Equity Offering in the amount of AUD 3.929624 million.Nuheara Limited has completed a Follow-on Equity Offering in the amount of AUD 3.929624 million. Security Name: Ordinary Shares Security Type: Common Stock Securities Offered: 3,846,154 Price\Range: AUD 0.13 Discount Per Security: AUD 0.0039 Security Name: Ordinary Shares Security Type: Common Stock Securities Offered: 19,458,649 Price\Range: AUD 0.13 Discount Per Security: AUD 0.0039 Security Name: Ordinary Shares Security Type: Common Stock Securities Offered: 6,923,077 Price\Range: AUD 0.13 Discount Per Security: AUD 0.0039 Transaction Features: Rights Offering
New Risk • Oct 19New major risk - Shareholder dilutionThe company's shareholders have been substantially diluted in the past year. Increase in shares outstanding: 62% This is considered a major risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-AU$10m free cash flow). Earnings have declined by 12% per year over the past 5 years. Shareholders have been substantially diluted in the past year (62% increase in shares outstanding). Minor Risks Revenue is less than US$5m (AU$1.9m revenue, or US$1.2m). Market cap is less than US$100m (AU$30.1m market cap, or US$19.0m).
分析記事 • Oct 09Does Nuheara (ASX:NUH) Have A Healthy Balance Sheet?David Iben put it well when he said, 'Volatility is not a risk we care about. What we care about is avoiding the...
Reported Earnings • Oct 03Full year 2023 earnings released: AU$0.084 loss per share (vs AU$0.16 loss in FY 2022)Full year 2023 results: AU$0.084 loss per share (improved from AU$0.16 loss in FY 2022). Revenue: AU$1.93m (down 50% from FY 2022). Net loss: AU$12.6m (loss narrowed 15% from FY 2022). Over the last 3 years on average, earnings per share has increased by 15% per year but the company’s share price has fallen by 48% per year, which means it is significantly lagging earnings.
お知らせ • Sep 15Nuheara Limited, Annual General Meeting, Nov 22, 2023Nuheara Limited, Annual General Meeting, Nov 22, 2023, at 09:00 W. Australia Standard Time. Location: Anzac Club, 28 St Georges Terrace, Perth WA Australia
New Risk • Aug 30New major risk - Financial positionThe company has less than a year of cash runway based on its current free cash flow trend. Free cash flow: -AU$10m This is considered a major risk. With less than a year's worth of cash, the company will need to raise capital or take on debt unless its cash flows improve. This would dilute existing shareholders or increase balance sheet risk. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-AU$10m free cash flow). Earnings have declined by 10% per year over the past 5 years. Shareholders have been substantially diluted in the past year (56% increase in shares outstanding). Minor Risks Revenue is less than US$5m (AU$1.9m revenue, or US$1.2m). Market cap is less than US$100m (AU$34.6m market cap, or US$22.4m).
お知らせ • Jul 18Nuheara Limited Announces Appointment of Catherine Morgan as Head of Compliance, Regulatory and LegalNuheara Limited announced the key Executive appointment of Catherine Morgan as the Head of Compliance, Regulatory and Legal. This appointment completes Nuheara's global restructure announced 28 April 2023 and cements the Company's transformation over the past two years into a medical device manufacturer of world-first US FDA- cleared Over The Counter (OTC) Hearing Aids. Catherine joins the Nuheara C-suite with over +20 years of experience in the hearing industry, bringing a deep understanding of the hearing healthcare, medical device industry, global regulatory requirements, and quality standards. In this new role Catherine will be responsible for driving regulatory strategies, ensuring adherence to global regulations and standards, and driving continuous improvement initiatives within quality management systems. They will collaborate closely with cross-functional teams to streamline regulatory submissions, enhance product quality, and foster a culture of continuous improvement in all aspects of regulatory and quality operations. Prior to joining Nuheara, Catherine held senior leadership positions at the National Acoustic Laboratories and more than 14 years with Cochlear Ltd. Catherine has a proven track record of successfully navigating complex regulatory landscapes and implementing strong clinical quality management processes and while fostering a culture of regulatory compliance and quality excellence within the hearing market.
New Risk • Jun 17New minor risk - Share price stabilityThe company's share price has been volatile over the past 3 months. It is more volatile than 75% of Australian stocks, typically moving 13% a week. This is considered a minor risk. Share price volatility indicates the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. It also increases the risk of potential losses in the short term as the stock tends to have larger drops in price more frequently than other stocks. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-AU$12m free cash flow). Earnings have declined by 13% per year over the past 5 years. Shareholders have been substantially diluted in the past year (97% increase in shares outstanding). Minor Risks Share price has been volatile over the past 3 months (13% average weekly change). Revenue is less than US$5m (AU$1.7m revenue, or US$1.1m). Market cap is less than US$100m (AU$34.5m market cap, or US$23.7m).
お知らせ • Jun 07Nuheara Limited has completed a Follow-on Equity Offering in the amount of AUD 4.4 million.Nuheara Limited has completed a Follow-on Equity Offering in the amount of AUD 4.4 million. Security Name: Ordinary Shares Security Type: Common Stock Securities Offered: 24,275,862 Price\Range: AUD 0.145 Security Name: Ordinary Shares Security Type: Common Stock Securities Offered: 6,068,966 Price\Range: AUD 0.145 Transaction Features: Subsequent Direct Listing
Reported Earnings • Mar 09First half 2023 earnings released: AU$0.048 loss per share (vs AU$0.065 loss in 1H 2022)First half 2023 results: AU$0.048 loss per share. Revenue: AU$765.6k (down 74% from 1H 2022). Net loss: AU$6.46m (loss widened 7.5% from 1H 2022).
Board Change • Feb 01Insufficient new directorsNo new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 8 experienced directors. No highly experienced directors. Independent Non-Executive Chairman Chery Edwardes was the last director to join the board, commencing their role in 2020. The following issues are considered to be risks according to the Simply Wall St Risk Model: Insufficient board refreshment.
お知らせ • Jan 04Nuheara Announces Commercial Availability of HP Hearing PRO OTC Hearing AidNuheara announced the commercial availability of its HP Hearing PRO. Consumers can now pre-order the HP Hearing PRO self-fitting, air-conduction, OTC hearing soon be able to purchase the product from any retailer carrying the product including Best Buy and Crutchfield. Nuheara's HP Hearing PRO is the first product cleared through the FDA's 510(k) process for both 874.3325 self-fitting and the 800.30 OTC hearing aid classifications under a new product classification code "QUH". HP Hearing PRO is the first FDA cleared self-fitting OTC hearing aid with Hybrid Active Noise Cancellation. The innovative Ear ID(TM) software-in-medical-device and earbud form factor sets the HP Hearing PRO apart from other devices on the market . The HP Hearing PRO self-fitting OTC hearing aids look nothing like a traditional hearing aid. The HP Hearing PRO self- fitting OTC hearing aid brings together superb medical-grade hearing aid technology with the highly desired features of wireless earbuds into a multifunctional device. Users can enjoy clinically-proven natural sound quality. The HP Hearing PRO provides a lifestyle-friendly hearing aid experience with support for situational use and clinically-proven 30% improved hearing using the Focus directionality feature, adjusted to the user's preferences with a tap of the HP Hearing app. Orders can now be placed from retailers and ecommerce partners throughout the US. The recommended retail price for a pair of HP Hearing PRO hearing aids along with an on-the-go charging case is USD 699.00. Product is expected to ship to customers before the end of calendar Quarter 1, 2023. Built to medical-device standards and meeting all FDA requirements for safety and efficacy, the HP Hearing PRO features Ear ID(TM) self-fitting software and technology powered by Nuheara. The HP Hearing PRO self-fitting OTC hearing aid has been clinically proven to be substantially equivalent to a professionally fit hearing aid. The proprietary Ear ID software tests the wearer's individual hearing thresholds from low frequency to high frequency in each ear, then automatically programs the HP Hearing PRO hearing aids for each ear. This ability for the consumer to self-fit through the HP Hearing application, for iOS and Android platform mobile devices, allows a quick and easy acclimation experience for the consumer. The entire experience takes about 10-15 minutes from unboxing through customization of the user's personalized profile to accommodate their perceived mild-to-moderate hearing loss. In addition to the HP Hearing PRO's capabilities as an OTC hearing aid, this innovative product streams media and phone calls via Bluetooth(R). The Active Noise Cancellation minimizes background noise for an immersive sound experience during phone calls or when streaming music. Additional features include: Hearing app for iOS and Android; Rechargeable built-in Li-ion batteries; Medical-grade USB-C charge case; Battery life is up to 8 hours hearing aid processing per full charge per hearing aid; Clinically-proven natural sound quality. Most importantly, the HP Hearing PRO has been clinically validated through research cometed by the National Acoustic c Laboratories to provide a 30% speech understanding improvement in the presence of noise using the directional microphone feature called Focus. This is a huge benefit for consumers in restaurants or social situations where background noise makes understanding speech difficult. Now, at the touch of the HP Hearing app, a wearer can switch the directional microphone settings to Focus on sounds towards their front, quickly allowing for immediate improvement in speech understanding.
お知らせ • Dec 30Nuheara Limited has completed a Follow-on Equity Offering in the amount of AUD 3.025401 million.Nuheara Limited has completed a Follow-on Equity Offering in the amount of AUD 3.025401 million. Security Name: Ordinary Shares Security Type: Common Stock Securities Offered: 16,807,781 Price\Range: AUD 0.18 Discount Per Security: AUD 0.0108 Transaction Features: Subsequent Direct Listing
お知らせ • Oct 31Nuheara Limited Receives US FDA Approval and Launches HP Hearing PRONuheara Limited announce a major milestone, receiving US Food and Drug Administration (FDA) clearance for its Self-Fitting OTC Hearing Aid. Nuheara's HP Hearing PRO has been cleared by the FDA for both 874.3325 self- fitting and the 800.30 OTC hearing aid classifications under a new product classification code "QUH". Following the landmark law establishing a regulatory category for over-the-counter (OTC) Hearing Aids in the United States (enacted on 17 October 2022) Nuheara plans to bring to market its first medical device as the HP Hearing PRO under its worldwide Trademark License Agreement for use of HP trademarks on Nuheara's hearing aids, personal sound amplification devices and accessories. ASX Announcement The HP Hearing PRO self-fitting OTC hearing aid brings superb medical grade hearing aid technology combined with highly desired features of wireless ear buds into a multifunctional device that will be sold in the US online and in retail stores, including Best Buy, Crutchfield, Amazon.com, and www.HPHearingPRO.com. Initial orders have been placed from retailers and ecommerce partners for availability throughout the US. The Release Date: 31 OCTOBER 2022 recommended retail price for a pair of HP Hearing PRO hearing aids along with a charge case for on-the-go charging is USD 699.00. The OTC hearing aid rule enactment in the US allows hearing aids within the OTC category, for perceived mild to moderate hearing loss, to be sold directly to consumers in retail stores or online. Access to hearing solutions in retail is something that Nuheara has been developing with its hearable products sales over the past 5 years. As such, the business is well placed to take immediate and significant advantage of the regulation changes.
お知らせ • Oct 27Nuheara Limited to Report Q1, 2023 Results on Oct 31, 2022Nuheara Limited announced that they will report Q1, 2023 results on Oct 31, 2022
お知らせ • Oct 21+ 1 more updateNuheara Limited Announces the Resignation of Jean-Marie Rudd as CFONuheara Limited announced that Jean-Marie Rudd has exited from her role as CFO, effective immediately. The company will shortly commence a search process for a new CFO to support the Company through its next growth phase.
Reported Earnings • Oct 07Full year 2022 earnings released: AU$0.16 loss per share (vs AU$0.10 loss in FY 2021)Full year 2022 results: AU$0.16 loss per share (further deteriorated from AU$0.10 loss in FY 2021). Revenue: AU$3.87m (down 64% from FY 2021). Net loss: AU$14.3m (loss widened 82% from FY 2021). Over the last 3 years on average, earnings per share has increased by 24% per year but the company’s share price has fallen by 35% per year, which means it is significantly lagging earnings.
お知らせ • Oct 06Nuheara Limited, Annual General Meeting, Nov 29, 2022Nuheara Limited, Annual General Meeting, Nov 29, 2022, at 09:00 W. Australia Standard Time. Location: head office, 190 Aberdeen Street, Northbridge, Western Australia. Northbridge Western Australia Australia
Reported Earnings • Sep 02Full year 2022 earnings released: AU$0.15 loss per share (vs AU$0.093 loss in FY 2021)Full year 2022 results: AU$0.15 loss per share (down from AU$0.093 loss in FY 2021). Revenue: AU$3.87m (down 64% from FY 2021). Net loss: AU$14.1m (loss widened 96% from FY 2021). Over the last 3 years on average, earnings per share has increased by 25% per year but the company’s share price has fallen by 19% per year, which means it is significantly lagging earnings.
お知らせ • Aug 19Nuheara Limited Welcomes US Food and Drug Administration's Final Ruling, Establishing A Regulatory Category for Over-The-Counter (Otc) Hearing Aids in the United StatesNuheara Limited welcomed the US Food and Drug Administration's final ruling, establishing a regulatory category for over-the-counter (OTC) Hearing Aids in the United States. In a world first, and most significantly for Nuheara, the ruling allows hearing aids within the OTC category to be sold directly to consumers in stores or online without a medical exam or fitting by an audiologist. There is now a 60-day enactment period until the commencement of OTC hearing aid consumer retail sales are allowed, anticipated for mid-October 2022. The US FDA received over 1,000 public comment submissions on the proposed rule change. The majority of submissions reflected that American people and healthcare professionals agreed on the significant positive impact that OTC hearing aids could have. The public comments also revealed, as expected, that the dominant hearing aid manufacturers strongly opposed the proposed rule, including using industry-funded "astroturf" campaigns intended to distort public opinion. Despite the incumbent hearing aid manufacturers' efforts to jeopardise such an important ruling, the FDA formally ruled in favourof the OTC category for hearing aids. This historical rule change will forever upend the hearing aid industry and unlock historical barriers to entry for the estimated 38 million Americans who experience some hearing loss. Currently in the US, hearing aids are sold at an average cost of USD 4,726 per pair and can be as much as USD 10,000 or more per pair through licensed audiologist and licensed hearing aid retailers. Now, with the ability for those with perceived mild to moderate hearing loss to purchase OTC, this cost could come down lower than USD 1,000 per pair of hearing aids.
分析記事 • Jul 30Here's Why Nuheara (ASX:NUH) Must Use Its Cash WiselyWe can readily understand why investors are attracted to unprofitable companies. For example, biotech and mining...
お知らせ • May 09Nuheara Limited Announces Executive ChangesNuheara Limited announced that the appointment of John R. Luna as its US based Chief Executive Officer; Co-founder and former CEO, Justin Miller, remaining as the company's Managing Director. John R. Luna joined Nuheara in May 2021 was and previously served as the Chief Revenue Officer and President Americas. John has a proven track record of successfully leading companies and commercializing medical devices over a 30-year career. In the medical device and hearing aid industry, John served previously as CEO and COO of iHear Medical Inc., Chief Business Development Officer of Eargo, and President and COO of Bernafon (Demant).
お知らせ • Apr 28Nuheara Limited has filed an IPO in the amount of AUD 5 million.Nuheara Limited has filed an IPO in the amount of AUD 5 million. Security Name: Ordinary Shares Security Type: Common Stock Securities Offered: 45,454,545 Price\Range: AUD 0.11
分析記事 • Apr 13Here's Why Nuheara (ASX:NUH) Must Use Its Cash WiselyWe can readily understand why investors are attracted to unprofitable companies. For example, although...
お知らせ • Apr 12Nuheara Submits 510(k) for U.S. FDA ClearanceNuheara Limited has taken the final step in its plans to secure US Food and Drug Administration (FDA) clearance for its self-fitting hearing aid by providing its 510(k) submission to the FDA. This follows completion of Nuheara's successful clinical trial by National Acoustic Laboratories (NAL) in January 2022. The trial successfully validated the effectiveness of the Nuheara self-fitted hearing aids compared to unaided listening across a range of settings and situations. The Nuheara hearing aids are designed to be self-fitted by the user, with a software application interface for both iOS and Android smartphones, intended for direct-to-consumer sale and use without the assistance of a hearing care professional. They are intended for individuals 18 years of age or older with perceived mild to moderate hearing loss, which makes up 85% of the US market. The FDA submission for clearance is the final step of Nuheara's expansion plans into the regulatory approved medical device market, which also aligns with the much-awaited U.S. Over-The-Counter Hearing Aid final rule publication in the Federal Register by the FDA expected for northern hemisphere mid-summer 2022.
お知らせ • Feb 16Nuheara Announces Executive ChangesNuheara announced the retirement of Co-founder, David Cannington as Chief Marketing Officer. Mr. Cannington will continue supporting Nuheara as a Non-executive Director. The Board thanks Mr. Cannington for his tireless efforts in helping build the business to this stage and look forward to his continued contribution as a member of the Company's Board. Promotion of Seattle-based John Luna to President Americas alongside his existing role of Chief Revenue Officer, effective immediately. Appointment of Tony Sulsona as VP Sales and Marketing, based in the US and effective immediately. Tony has 30 years' experience building medical and consumer product companies in the US.
お知らせ • Feb 01Nuheara Limited Announces Successful Clinical Trial Self-Fitted Hearing AidsNuheara Limited announced that is has successfully concluded its hearing aid clinical trial with the final report received from National Acoustic Laboratories. The clinical trial completes a very complex and important milestone for Nuheara on its pathway to an FDA 510(K) submission and pending entrance into the regulated U.S. hearing aid market segment with world leading hearing aid products. The clinical trial was conducted in Australia using Audiology best practices on participants with normal hearing and those with mild and moderate hearing loss by professional clinical Audiologists and clinical researchers at NAL. The trial successfully validated the hearing benefit of the Nuheara self-fitted hearing aids compared to unaided listening with benefits including Improved speech understanding in noise; Improved ability to follow conversations; Ability to reduce background noise levels; Overall hearing improvement when listening in everyday conversations. In relation to the unaided listening condition, the study data provided evidence of the superiority of Nuheara hearing aids with FOCUS enabled over unaided listening, and of substantial effectiveness of the Ear IDTM self- fitted hearing aid devices in the overall experience of listeners. Furthermore, clinical assessment showed improvement in speech understanding by 30% in noise when the Nuheara hearing aids FOCUS feature was enabled. This outcome is consistent with other studies showing advantages in speech understanding in noise with conventional directional microphones in hearing aids ranging from 25% to 30% improvement, depending on the familiarity to the speech, physical fitting, and design of the hearing aids. The effectiveness data of the Nuheara Ear IDTM self-fitting method was also validated, as Software in a Medical Device (SiMD), through clinical and real-world data demonstrating positive outcomes as compared to the expected NAL-NL2 clinical targets that would be performed by an audiologist fit hearing aid in a clinic.
お知らせ • Jan 28Nuheara Limited to Report Q2, 2022 Results on Jan 31, 2022Nuheara Limited announced that they will report Q2, 2022 results on Jan 31, 2022
お知らせ • Jan 06Nuheara Clinical Trial and FDA 510(K) Pathway UpdateNuheara Limited provided an update on its clinical trial and pathway to FDA 510(K) submission¹ for the Company's pending entrance into the U.S. hearing aid market, in line with its expansion plans into global medical devices. The Nuheara sponsored clinical trial, conducted by National Acoustics Laboratory (NAL), has been completed with all participants data now collected. NAL is expected to publish the final clinical trial report by the end of January 2022. This is an important milestone on the path to US FDA 510(K) submission and regulatory clearance.
分析記事 • Dec 24We Think Nuheara (ASX:NUH) Needs To Drive Business Growth CarefullyJust because a business does not make any money, does not mean that the stock will go down. For example, although...
お知らせ • Nov 25Nuheara Limited Provides Update on Clinical Trial and Pathway to FDA 510(K) ApprovalNuheara Limited provided an update on its clinical trial and pathway to FDA 510(K) approval for the Company's clinically tested and regulatory approved hearing aids, in line with its expansion plans into medical devices. Recruitment of candidates for the clinical trial being conducted by National Acoustics Laboratory has now been completed. This is an important milestone on the path to regulatory approval. Of further significance, more than 50% of candidates have now commenced the trial, with the remaining candidates expected to commence within the next week. Nuheara has also engaged NAMSA, the world's only 100% medical device-focused contract research organisation, and a U.S. FDA ASCA-accredited medical device biocompatibility laboratory, to conduct Cytotoxicity, Irritation and Sensitisation testing. The testing was conducted in accordance with ISO standards, to demonstrate biocompatibility of Nuheara's proposed hearing aid devices. In accordance with these standards, the following excellent results were recorded: Cytotoxicity testing was found to meet requirements. Irritation testing outcomes resulted in a Primary Irritation Index of zero. Sensitisation testing showed no evidence of contact sensitisation.
分析記事 • Aug 25Is Nuheara (ASX:NUH) In A Good Position To Deliver On Growth Plans?We can readily understand why investors are attracted to unprofitable companies. For example, although...
Reported Earnings • Aug 18Full year 2021 earnings released: AU$0.005 loss per share (vs AU$0.011 loss in FY 2020)The company reported a solid full year result with reduced losses, improved revenues and improved control over expenses. Full year 2021 results: Revenue: AU$10.7m (up AU$9.00m from FY 2020). Net loss: AU$7.20m (loss narrowed 38% from FY 2020). Over the last 3 years on average, earnings per share has increased by 15% per year but the company’s share price has fallen by 24% per year, which means it is significantly lagging earnings.
お知らせ • Mar 10Nuheara Limited Receives U.S. FDA Registration and Hearing Aid Device ListingNuheara Limited announced that the company has received U.S. Food and Drug Administration establishment registration for a medical device listing of a new hearing aid, IQbuds² PRO. The PRO, alongside IQbuds MAX, will be second product to be derived from the recently developed IQbuds² hardware platform. With software developments currently in train, the PRO has been designed to provide deeper levels of hearing technology sophistication, while delivering higher levels of hearing enhancement and amplification. The PRO is expected to be launched in the US later in the calendar year. The PRO has received FDA classification as a "HEARING AID, AIR CONDUCTION WITH WIRELESS TECHNOLOGY", Device Class 2 510(k) exempt with an OSM product code. As with all hearing aids classified with the OSM product code, the FDA has classified the PRO as 510(k) exempt. This means the PRO can be sold in the U.S. without the need to conduct clinical trials or submit a 510(k) application. The company’s multi-product strategy has been planned to maximise the company's global sales opportunities by offering multiple products that support varying degrees of hearing loss. MAX will continue to meet the needs of those with mild hearing challenges. The PRO is designed to support adults with higher (moderate) levels of hearing loss and will extend Nuheara's Direct-to-Consumer strategy to the global USD 9billion per annum (North America USD 3.37 billion) hearing aid market.
Reported Earnings • Feb 24First half 2021 earnings released: AU$0.001 loss per share (vs AU$0.006 loss in 1H 2020)The company reported a solid first half result with reduced losses, improved revenues and improved control over expenses. First half 2021 results: Revenue: AU$6.91m (up 406% from 1H 2020). Net loss: AU$842.2k (loss narrowed 85% from 1H 2020). Over the last 3 years on average, earnings per share has increased by 2% per year but the company’s share price has fallen by 15% per year, which means it is significantly lagging earnings.
分析記事 • Jan 14What Can We Make Of Nuheara's (ASX:NUH) CEO Compensation?Justin Miller is the CEO of Nuheara Limited ( ASX:NUH ), and in this article, we analyze the executive's compensation...
お知らせ • Jan 08Nuheara Limited has completed a Follow-on Equity Offering in the amount of AUD 11.5 million.Nuheara Limited has completed a Follow-on Equity Offering in the amount of AUD 11.5 million. Security Name: Ordinary Shares Security Type: Common Stock Securities Offered: 287,500,000 Price\Range: AUD 0.04 Discount Per Security: AUD 0.0024 Transaction Features: Subsequent Direct Listing
お知らせ • Dec 30+ 1 more updateNuheara Limited announced that it expects to receive AUD 11.5 million in fundingNuheara Limited (ASX:NUH) announced a private placement of 287,500,000 common shares at a price of AUD 0.04 per share for a gross proceeds of AUD 11,500,000 on December 29, 2020. The transaction price of $0.04 represents a 9% discount to the last closing price on 23 December 2021 of $0.044 and an 17% discount to the 15-day VWAP of $0.0483 per Share.
お知らせ • Nov 27Nuheara Limited Appoints Warwick Sauer as DirectorNuheara Limited appoints Warwick Sauer as director at its AGM held on 27 November 2020.
分析記事 • Nov 22Is Nuheara (ASX:NUH) Using Debt In A Risky Way?The external fund manager backed by Berkshire Hathaway's Charlie Munger, Li Lu, makes no bones about it when he says...
お知らせ • Oct 13Nuheara Receives $2 Million Phase II Works with HP IncNuheara Limited announced a phase II extension of the collaboration agreement with HP Inc. On successfully completing a Proof of Concept (POC), Nuheara has now been awarded a $2 million (USD 1.48 million) Phase II Purchase Order (PO) for works associated with the development and engineering of an ear bud variant specific to HP's confidential use case. Phase I was previously awarded for accompanying software services.
お知らせ • Aug 29Nuheara Limited announced that it has received fundingNuheara Limited (ASX:NUH) announced a private placement of 1,000,000 shares on August 21, 2020.