All items tagged with FDA (9)

OTC Hearing Aids One Year Later – Mission Accomplished?

November 3, 2023 by Andrew Bellavia

OTC Hearing Aids One Year Later – Mission Accomplished?

The White House blog of August 2022 announcing the FDA’s release of the Over-the-Counter (OTC) hearing aid rule, which would take effect that October, highlighted the rationale for its creation: “Drive down costs, increase access, and open up a market space for creative innovation.” Andrew Bellavia (AuraFuturity) writes about the first year of the Over-the-Counter (OTC) hearing aid rule. It seems that just 2% of those with hearing difficulties purchased an OTC hearing aid in this time.

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.

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.

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.

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.

Bose Unveils SoundControl FDA-Cleared Direct-to-Consumer Hearing Aids

May 11, 2021 by Joao Martins

Bose Unveils SoundControl FDA-Cleared Direct-to-Consumer Hearing Aids

Bose was the first company to receive an FDA approval for an over-the-counter (OTC) hearing assistance device. The audio industry has been waiting for the actual product announcement. Now, Bose unveiled the SoundControl Hearing Aids, which as the name implies, are actual self-fitting, direct-to-consumer hearing-aids. They can be personalized using a mobile app, but the SoundControl Hearing Aids do not stream music or take calls and they retail for $849.95.

Automotive Audio and Cutting-Edge Audio Technologies in audioXpress June 2020

May 8, 2020 by audioXpress Staff

Automotive Audio and Cutting-Edge Audio Technologies in audioXpress June 2020

audioXpress June 2020 is now available, and for the first time in the publication's history, we have explored the fascinating world of automotive audio technology, and the relevant trends and opportunities. Elia Shenberger (CEVA) writes about Our Future Car and Birgit Bartel-Kurz (Fraunhofer IIS) discusses how to offer surround sound in cars. And Oliver Masciarotte reviews the Sennheiser AMBEO Immersive Soundbar, while Erica Yorga (Nureva) details a Real-Time Calibration Method for Acoustic Echo Cancellation. And there's so much more in this edition. Download or view your issue online now.

FDA Authorizes Bose Hearing Aid Device to Enter the Market as First Self-Fitting Hearing Aid Controlled by the User

October 8, 2018 by Joao Martins

FDA Authorizes Bose Hearing Aid Device to Enter the Market as First Self-Fitting Hearing Aid Controlled by the User

The U.S. Food and Drug Administration (FDA) allowed marketing of a new device, the Bose Hearing Aid, intended to amplify sounds for individuals 18 years or older with perceived mild to moderate hearing impairment (hearing loss). This is the first hearing aid authorized for marketing by the FDA that enables users to fit, program and control the hearing aid on their own, without assistance from a health care provider.