Like last year, in spite of a global pandemic, the hearing care space continued to innovate and evolve in 2022. Legislative changes, industry developments and disruptive technologies were among this year’s list of ‘most read’ hearing news and technology stories.
Top Stories of 2022
1) FDA Issues Final OTC Hearing Aid Rule and PSAP Guidance
In what comes as no surprise, the industry had been awaiting the final OTC hearing aid rule for years. In August, the U.S. Food and Drug Administration issued a final rule to establish a new category of over-the-counter (OTC) hearing aids, enabling consumers with perceived mild to moderate hearing impairment to purchase hearing aids directly from stores or online retailers without the need for a medical exam, prescription or a fitting adjustment by a professional.
Auracast™ broadcast audio enables an audio transmitter, such as a smartphone, laptop, television, or public address system to broadcast audio to an unlimited number of nearby Bluetooth audio receivers, including speakers, earbuds, or hearing devices.
3) FDA Approves Clinical Trial of First Fully Implanted Cochlear Implant
In June of this year, the U.S. Food and Drug Administration approved its Investigational Device Exemption (IDE) application to begin a clinical trial with its fully implanted Acclaim® cochlear implant. Envoy Medical’s single-center Early Feasibility Study for the Acclaim recently took place at Mayo Clinic in Rochester, Minn.
4) Best Buy to Launch New Experience for Customers with Hearing Loss
The new experience includes an expanded collection of hearing devices, an in-store experience in more than 300 stores, and a new online hearing assessment tool. Products available in the experience are said to include devices from Lexie Hearing, Nuheara, Eargo, Jabra, and more.
5) CMS to Allow Direct Access to Audiologists for Medicare Beneficiaries in 2023 for Hearing Exams
The finalized direct access policy will allow beneficiaries, once every 12 months, to receive care for “non-acute hearing assessments that are unrelated to disequilibrium, hearing aids, or examinations for the purpose of prescribing, fitting, or changing hearing aids”
6) Bose Reported Exit from Selling Hearing Aids; Partnership with Lexie
As a category pioneer for self-fitting OTC hearing aids, the industry was shocked by media reports of Bose’s abrupt exit from the hearing aid industry in May, prior to the release of the final OTC rule by the FDA. In July, the company announced it was forming a partnership with Lexie Hearing to bring its self-fitting technology to the DTC device maker.
7) Sonova Acquires Alpaca Audiology Network
Demonstrating the continued importance of retail clinics, in January of 2022 Sonova signed an agreement to acquire Alpaca Audiology, one of the largest independent networks of audiological care clinics in the US for approximately $310 million dollars. Founded in 2011, the company has over 500 employees and operates around 220 clinics across the country.
8) Sony Announces Launch of First OTC Hearing Aids in the US
In October, Sony Electronics announced the availability of its first over-the-counter (OTC) hearing aids for the U.S. market. The first two products to debut from the partnership with WS Audiology are the CRE-C10 and the CRE-E10 self-fitting OTC hearing aids, offered at a retail price of $999 and $1299 respectively per pair.
9) Cochlear to Acquire Oticon Medical as Demant Divests Implants Business
In April, Demant announced that it has negotiated an agreement with the intention to divest its Hearing Implants business, Oticon Medical, to Cochlear Limited for a total consideration of DKK 850 million ($120M USD). The transaction follows a review of strategic options for the business, including how to ensure the best lifelong support of existing patients.
