Tag: FDA



Knowles Introduces New Balanced Armature Receiver for OTC Market

Knowles Corporation, a provider of advanced micro-acoustic microphones, speakers, audio solutions, high-performance capacitors, and RF products, announced the RAQ, a new medium-power balanced armature receiver developed for high-volume hearing health and TWS products.

NAAG Urges FDA to Preserve State Regulation of OTC Hearing Aids

The National Association of Attorneys General (NAAG) cautions that OTC hearing aid rules currently under review by the FDA may unintentionally hinder or repeal important consumer protection authorities, undermining states’ ability to ensure safe and affordable access to hearing aids. Currently, all 50 states have hearing professional licensing requirements and many have important protections for hearing aid consumers, including advertising restrictions, as well as mandatory warrantees and returns.

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Gene Therapy for Hearing Loss Reversal

Hearing loss has been linked to mutations in at least 100 different genes, but up to 16% of genetic hearing loss can be traced to just one gene, STRC, the second most common genetic cause. A first-of-its-kind gene therapy technique developed at Boston Children’s Hospital successfully replaced the mutated protein, stereocilin, in the inner ear and reversed severe hearing loss in mice — sometimes to normal levels of hearing.

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FDA Issues Proposed OTC Hearing Aid Rules

To ensure patient safety, the proposed rule addresses maximum output limits and includes certain device performance and design requirements, such as distortion control limits, self-generated noise limits, latency limits, frequency bandwidth, as well as a requirement to limit the insertion depth of the device. The proposed rule also includes labeling requirements for OTC hearing aids. As hoped, the FDA also issued an updated draft guidance, “Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products (PSAPs).”

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Neuromod Appoints Eric Timm as US CEO

Neuromod Devices Ltd, the medical device company which specializes in neuromodulation technologies, has announced the appointment of Eric Timm as Chief Executive Officer of its recently established US entity, Neuromod USA Inc, effective from October 1, 2021.

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