All items tagged with OTC (33)

OTC Hearing Aids: Is Innovation Leaving the Rule Behind?

February 15, 2023 by Andrew Bellavia

OTC Hearing Aids: Is Innovation Leaving the Rule Behind?

A wave of new developments promises to solve the most pressing need for people with milder hearing loss, allowing mass-market hearables to supplant Over-the-Counter (OTC) hearing aids with less stigma. Andrew Bellavia suggests the FDA’s OTC hearing aid rule (October 2022) includes assumptions that are quickly becoming obsolete as recent developments illustrate. This must read article was originally published in audioXpress, January 2023.

Hearables in 2023: Comfort Must Come First

January 5, 2023 by Andrew Bellavia

Hearables in 2023: Comfort Must Come First

Predicting what trends we’ll see in hearables in 2023 seems like a fool’s errand. With the release of the OTC hearing aid rule in the United States, these are predicated on devices that can be comfortably worn for long stretches of the day in a form factor that people are willing to wear in social settings. Without that foundation, these interesting and useful applications will not achieve mass-adoption. Anticipating CES 2023, Andrew Bellavia looks for the Next Big Thing in Hearables and the Multiple Sides of Comfort.

Knowles Releases New Balanced Armatures and MEMS Microphones for OTC Hearing Aids

December 21, 2022 by audioXpress Staff

Knowles Releases New Balanced Armatures and MEMS Microphones for OTC Hearing Aids

Knowles Corporation is showcasing its latest solutions optimized for over-the-counter (OTC) hearing aids at the CES 2023 show in Las Vegas. The new product releases unveiled ahead of the show offer performance and design flexibility to accelerate the production of hearing health products. Three full-range balanced armature receivers and two updated MEMS microphones will fulfill the rigorous demands of hearing aid design and acoustic performance.

HearUSA to Carry Sony’s Over-the-Counter Hearing Aids

December 15, 2022 by audioXpress Staff

HearUSA to Carry Sony’s Over-the-Counter Hearing Aids

Responding to the Food and Drug Administration’s recent approval of over-the-counter (OTC) hearing aids, HearUSA announced that it will offer Sony’s new over-the-counter hearing aids. The first two models – the Sony CRE-C10 and Sony CRE-E10 – will be available for clients to purchase early next year in all HearUSA centers and online. These solutions result from Sony's joint development with WS Audiology Denmark with the aim of supplying products and services in the OTC self-fitting hearing aid space.

Nuheara Receives FDA Clearance for Self-Fitting OTC Hearing Aids and Launches HP Hearing PRO

October 31, 2022 by Joao Martins

Nuheara Receives FDA Clearance for Self-Fitting OTC Hearing Aids and Launches HP Hearing PRO

Australian hearable pioneers Nuheara announced that the company has received the "historic and first of its kind" FDA 510(k) premarket clearance for both an 874.3325 Self-fitting Hearing Aid and the 800.30 Over The Counter (OTC) hearing aid classification. This gives clearance for Nuheara to launch a "Self-Fitting Air-Conduction Hearing Aid, Over The Counter" product, which will be launched in the US market as the HP Hearing PRO.

Lexie Hearing Announces Lexie B2 Hearing Aids, Powered by Bose

October 11, 2022 by audioXpress Staff

Lexie Hearing Announces Lexie B2 Hearing Aids, Powered by Bose

Short after the announcement of the partnership to bring Bose’s self-fitting hearing aid technology to the Lexie Hearing product line and the launch of the Lexie B1 Hearing Aids, the two companies have announced the launch of the Lexie B2 Hearing Aids, Powered by Bose, adding a third hearing aid model to its suite of audiologist-quality hearing aid products. This is the second development in partnership with Bose and, unlike the B1, the B2 hearings aids are fully rechargeable.

Sony and WS Audiology Sign Partnership Agreement for Over-the-Counter Self-Fitting Hearing Aids

September 13, 2022 by Joao Martins

Sony and WS Audiology Sign Partnership Agreement for Over-the-Counter Self-Fitting Hearing Aids

Following the recently issued rule establishing Over-the-Counter (OTC) hearing aids by the US Food and Drug Administration (FDA), Sony Corporation and WS Audiology Denmark A/S have entered into a partnership agreement and various ancillary agreements with the aim of jointly developing and supplying new products and services in the OTC self-fitting hearing aid market, beginning with the United States. US consumers will be the first to be able to buy Sony-branded hearing assistive products.

Serving a Purpose: OTC Hearing Aids, Hearing Enhancement, and Brands

August 25, 2022 by Joao Martins

Serving a Purpose: OTC Hearing Aids, Hearing Enhancement, and Brands

If you are an audio industry professional, unless you have been on holiday on some remote island without Internet, you must have noticed that the US Food and Drug Administration (FDA) finally issued the long-expected rule establishing Over-the-Counter (OTC) hearing aids - five years after the original OTC hearing aid act was signed into law on August 18, 2017. Will hearing aid companies really adjust and understand "consumer" behaviors? How do hearables fit in that environment? Could these products be influenced by "brand loyalty"?

GN Announces Jabra Enhance Plus will Enter OTC Hearing Aid Category

August 18, 2022 by Joao Martins

GN Announces Jabra Enhance Plus will Enter OTC Hearing Aid Category

Following the FDA release of the anticipated Over-the-Counter (OTC) hearing aid regulations, with intent to increase access for people with untreated hearing loss, the GN Group immediately announced its support to that ambition. The market leading group that owns hearing aid brands Resound and Beltone, together with Jabra, the communications and all-in-one hearing enhancement consumer brand, announced that it will seek to register its Jabra Enhance Plus technology as an OTC product.

US Food and Drug Administration Finalizes Rules for Over-the-Counter Hearing Aids

August 18, 2022 by Joao Martins

US Food and Drug Administration Finalizes Rules for Over-the-Counter Hearing Aids

Five years after the original OTC hearing aid act was signed into law on August 18, 2017, the US Food and Drug Administration (FDA) issued a final rule establishing Over-the-Counter (OTC) hearing aids. The FDA also issued the final Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products, clarifying the differences between hearing aids, which are medical devices, personal sound amplification products, and the new category of OTC hearing aids, which can be purchased directly from stores or online.

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