All items tagged with over-the-counter (50)

Jabra Rebrands Lively as JabraEnhance.com Online Destination for Better Hearing

November 9, 2022 by audioXpress Staff

Jabra Rebrands Lively as JabraEnhance.com Online Destination for Better Hearing

GN has expanded its Jabra Enhance hearing offering with integration and rebrand of Lively, acquired in 2021. The now rebranded JabraEnhance.com online hearing care platform is intended to enable US consumers to explore, purchase and receive hearing care from home. Joining the Jabra Enhance hearing aid range are also three Jabra Enhance Select products, available exclusively at JabraEnhance.com.

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.

Sony Electronics Launches its First Over-the-Counter Hearing Aids in the US

October 12, 2022 by Joao Martins

Sony Electronics Launches its First Over-the-Counter Hearing Aids in the US

It didn't take long. A month past from the partnership agreement announcement between Sony Corporation and WS Audiology Denmark A/S with the aim of jointly developing and supplying new products and services in the OTC self-fitting hearing aid market, Sony has already announced the first two products for the Over-the-Counter (OTC) hearing aids space in the US market. The two products to debut from the partnership are the CRE-C10 and the CRE-E10 self-fitting OTC hearing aids.

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.

Bose Self-Fitting Hearing Aids Are Now Lexie Hearing Aids Powered by Bose

July 27, 2022 by Joao Martins

Bose Self-Fitting Hearing Aids Are Now Lexie Hearing Aids Powered by Bose

Bose Corporation and Lexie Hearing, a direct-to-consumer hearing aid provider in the United States and 39 other countries, announced a partnership to bring Bose’s self-fitting hearing aid technology to the Lexie Hearing product line. The new Lexie B1 Hearing Aids will be marketed as "Powered by Bose," allowing wearers to fit, program, and control their hearing aids with clinically proven, audiologist-quality results — without a doctor visit, hearing test, or prescription.

Fresh From the Bench: Olive Pro Hearing and Bluetooth Earbuds

April 21, 2022 by Brent Butterworth

Fresh From the Bench: Olive Pro Hearing and Bluetooth Earbuds

The Olive Pro Hearing and Bluetooth Earbuds were brought to market by Olive Union during 2021. These are 2-in-1 true wireless earbuds and smart (FDA-Registered class II) hearing aids, featuring a modern design that was intentionally conceived to look like futuristic Bluetooth earbuds to combat the social and economic barriers of hearing loss. When the company temporarily paused its sales efforts in the US, Brent talked with the company to find out what happened and their plans to adjust and return to market. This article was originally published in audioXpress, January 2022.

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