Sennheiser Introduces All-Day Clear Over-the-Counter Hearing Aids

Sennheiser Hearing has introduced a new model of over-the-counter hearing aids that the company defines as a new class of devices, allowing US consumers access to powerful assistive hearing technology on their own terms. The FDA-approved All-Day Clear and All-Day Clear Slim are traditional looking behind-the-ear (BTE) hearing aids that combine speech enhancement with self-fitting features to complete "a refreshing, uncomplicated ownership experience."

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.

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.

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"?

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.

Making Audio Augmentation useful for everyone, or pursue the regulatory requirements of OTC hearing aids. This article offers a useful perspective regarding the guidance documents published by the US Food and Drug Administration regarding improved access to hearing aid technology. The agency proposes a rule to establish a new category of over-the-counter (OTC) hearing aids - to be sold directly to consumers in stores or online without a medical exam or a fitting by an audiologist. But most audio manufacturers are better off by not pursuing this FDA-approved OTC market. Doing so will simply hinder critical experimentation and innovation.