All items tagged with over-the-counter (53)

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.

April 5, 2022 by Joao Martins

Olive Union Returns With Brand New Olive Max Adaptive Hearing Enhancers

After debuting its Olive Pro 2-in-1 FDA-Registered class II hearing aids in 2020, smart hearing company Olive Union returns with a second and more ambitious product. The new Olive Max take the concept of affordable hearing health a step further, exchanging the convenience of compact true wireless earbuds for a large, around-the-ear (wrap-around) form-factor that the Japan-based company believes will be able to deal even with severe hearing loss.

Knowles Introduces New Balanced Armature Receiver Targeting Over-The-Counter Hearing Aid and TWS Market

February 15, 2022 by audioXpress Staff

Knowles Introduces New Balanced Armature Receiver Targeting Over-The-Counter Hearing Aid and TWS Market

Knowles Corporation announced the RAQ, a new medium-power, full-range balanced armature receiver developed for high volume hearing health and TWS products. The balanced armature receiver’s small size and high output delivers up to 116dB Sound Pressure Level (SPL) at 500Hz, making it optimally positioned to meet the performance requirements for both hearing health and True Wireless Sound (TWS) products.

GN Group Announces Launch of Jabra Enhance Plus Hearing Enhancement Earbuds

February 8, 2022 by Joao Martins

GN Group Announces Launch of Jabra Enhance Plus Hearing Enhancement Earbuds

A day past from the introduction of a new, category-defining hearing-aid model from ReSound, another GN Group brand announces the launch of a new hearing enhancement convergence product. The new Jabra Enhance Plus are described as true wireless earbuds designed to bring hearing enhancement for clearer conversations, as well as music and calls in a state-of-the-art miniaturized design. They look like regular TWS earbuds, but are in fact OTC-class self-fitting hearing aids.

CEVA Partners with Mimi Hearing Technologies to Offer Assistive Hearing on True Wireless Earbuds

December 13, 2021 by audioXpress Staff

CEVA Partners with Mimi Hearing Technologies to Offer Assistive Hearing on True Wireless Earbuds

CEVA and Mimi Hearing Technologies have announced a partnership to enable new assistive hearing capabilities in consumer true wireless earbuds. The collaboration combines Mimi Sound Personalization technology and advanced hearing IP with CEVA's Bluebud wireless audio platform to enhance the hearing experience of every individual. With its flexible architecture, the Bluebud platform allows a high level of software customization and add-ons, supporting such advanced implementations.

Reading Glasses and Hearing Aids. Smart or FDA-Approved. Pick One.

November 11, 2021 by Joao Martins

Reading Glasses and Hearing Aids. Smart or FDA-Approved. Pick One.

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.

xMEMS Piezo Microspeakers - The Future of Direct-to-Consumer Hearing Health Devices

June 4, 2021 by Mike Klasco

xMEMS Piezo Microspeakers - The Future of Direct-to-Consumer Hearing Health Devices

Mike Klasco writes about xMEMS Piezo Microspeakers. How Piezo MEMS Address Development Challenges to Combine the Compact, Consumer-Friendly Form Factor of TWS With Hearing Assistance Features Into a Single Product. How Piezoelectric MEMS Microspeakers devices promise to enhance OTC hearing augmentation solutions, increasing comfort, while adding features and extending battery life. This article was originally published in The Audio Voice newsletter, June 3, 2021 (#330)

Jacoti Announces OTC Ready Technologies for Over-the-Counter Hearing Aid Development Using Qualcomm 51XX SoCs

June 2, 2021 by audioXpress Staff

Jacoti Announces OTC Ready Technologies for Over-the-Counter Hearing Aid Development Using Qualcomm 51XX SoCs

Following the announcement of collaboration with Qualcomm, in October 2020, Jacoti BV, the Belgium-based medical technology company, now announced the immediate licensing availability of OTC Ready, Jacoti’s hearing software platform. OTC Ready enables headphone/earbud manufacturers using Qualcomm 51XX SoCs to address the likely requirements of the upcoming US over-the-counter hearing aid market.

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