Nuheara IQbuds™ BOOST, a personal sound amplification product (PSAP) device, will be carried by ADCO Medical Suppliers, a General Services Administration (GSA) contract holder authorized to supply audiological equipment to the US federal government, including the VA.
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The mainstream business press featured articles this week on the wealth being generated by manufacturing and distributing hearing aids, with mentions of Amplifon’s Susan Carol Holland, Starkey’s Bill Austin, Phonak’s Hans-Ueli Rihs, and IntriCon’s Mark Gorder.
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The new Livio AI hearing aid contains several firsts and is designed as a multi-functional device, or what Starkey is calling a “Healthable” hearing technology. In addition to hearing-related technology improvements, new features include fall-detection and inertial sensors, fitness and wellness tracking, a real-time language translator, and the ability to control the aid by just tapping it. The “ecosystem” that makes up the the new device is said to revolve around artificial intelligence (AI), machine learning, cloud computing, embedded 3D motion sensors, telehealth, language translation, fall detection and alerts, and hearing aid accessories.
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Signia’s new Styletto is a rechargeable SLIM RIC that features a contemporary design and breaks the mold of traditional BTE hearing aids by taking advantage of how its lithium-ion battery technology doesn’t need to conform to the traditional size and shape of a button cell.
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It’s time to clearly distinguish professional service from self-service by showing why licensed hearing care professionals can make a huge difference in hearing aid outcomes. Let’s commit to getting consumers a list of essentials by creating a voluntary standard protocol for every licensed professional who dispenses hearing aids. Let’s spell out what consumers should expect. And then let’s promote the hell out of it.
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Dr Barry Freeman answers questions about how long a hearing aid battery should last, and if you should clean the hearing aid and charger contacts. Get new insights into power issues, and ask your own questions here!
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The Hearing Industries Association (HIA) has announced its endorsement of the five recommendations made in the consensus paper by AAA, ADA, ASHA, and IHS titled, “Regulatory Recommendations for OTC Hearing Aids: Safety & Effectiveness”.
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The unprecedented consensus statement from four national hearing care professional organizations recommends the new FDA classification be called “Self-fit OTC hearing devices.” The paper recommends the new class be intended for mild-to-moderate hearing losses of 26-55 dB HL (26 max HFA-FOG/110 dB max output), offer input compression and volume controls, contain clear and easy-to-understand labeling both on the inside and outside of the packaging, and require at last one 510(k) filing for initial FDA approval to ensure the basic safety and efficacy of the device.
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This week, Dr Barry Freeman answers questions about how temperature and humidity influences battery life, and why hearing aid apps can’t be used to track the service life of silver-zinc rechargeable batteries. Get new insights into power issues, and ask your own questions here!
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William Demant—parent group of Oticon, Sonic, and Bernafon—has announced a licensing agreement with Philips to bring Philips-branded solutions to hearing healthcare. Combining William Demant’s hearing aid technology with Philips’ global brand presence in healthcare, the cooperation will enrich the hearing healthcare experience and support the healthy lifestyle and active life of even more people with hearing loss, say the companies.
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As the result of a whistleblower lawsuit, 3M has agreed to pay $9.1 million to resolve allegations that it knowingly sold its dual-ended Combat Arms Earplugs, Version 2 (CAEv2) to the US military without disclosing defects that hampered the effectiveness of the hearing protection device.
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The Centers for Medicare & Medicaid Services (CMS) published a request for information about how to address any undue regulatory impact and burden of the physician self-referral law—commonly referred to as the Stark Law. The request appeared in the June 25 Federal Register, and the deadline for comments is August 24.
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Amplifon SpA has announced its intent to purchase the privately owned GAES Group, Spain’s largest hearing aid distributor, for €528 million (US$616.6 million). “This major acquisition represents a key milestone in the history of our company and perfectly fits Amplifon’s growth strategy, allowing us to consolidate our global leadership and enabling us to become a market leader in Spain, as well as consolidate our market position in Portugal while also entering the Latin American region,” said Amplifon CEO Enrico Vita.
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MED-EL USA, Durham, NC, has been granted FDA de novo clearance for the BONEBRIDGE™ bone conduction hearing implant system for individuals 12 years and older who have been diagnosed with conductive hearing loss, mixed hearing loss, or single-sided deafness.
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A letter by the FDA’s William Maisel cautions that hearing devices cannot use “OTC hearing aids” in their marketing since the FDA definition of this hearing aid class—which would probably include severity of loss and other important safety, quality, and labeling requirements—has not yet been established.
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