Author: Karl

Evaluating Apple AirPods Pro with Headphone Accommodations as Hearing Devices

Researchers from NAL provide objective measures that characterize the acoustic performance of AirPods Pro headphones. The results suggest that, while differences to traditional hearing aids exist, the device’s Headphone Accommodations provide amplification to help people with mild-to-moderate hearing loss hear sounds more easily and allow them to experience the benefits of amplification.

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Senate Mulls “Build Back Better Act” and Coverage of Hearing Aids by Medicare

The $1.9 trillion Build Back Better Act was passed by the US House of Representatives on Friday, November 19, and is now with the Senate for what is sure to be a bumpy ride. The bill includes coverage of hearing aids once every 5 years for people with severe to profound hearing loss, as well as funding for universal preschool, expanded Child Tax Credits, several health and pandemic-related initiatives, renewable energy credits, and more.

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FDA Proposed Rules for OTC Hearing Aids Extend Beyond OTC

The 114-page rules document published today in the Federal Register covers most aspects related to OTC hearing aid manufacturing, electroacoustic requirements, packaging and labeling, returns, and conditions for sale. In an effort to promote more consistency in the regulations and enforcement of hearing aid manufacturing and distribution, the FDA is also proposing several important changes that could affect the industry and state-wide hearing aid dispensing.

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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 As hoped, the FDA also issued an updated draft guidance, “Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products (PSAPs).”

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GN Hearing to Delay Key 2021 Product Launches, Restructure R&D

GN Hearing, the parent company of ReSound and Beltone, announced in a profit warning that it is experiencing delays in product development deliverables leading to postponement of key product launches planned for H2 2021. The company has decided to initiate a transformation of R&D with the objective to increase quality, predictability of delivery times, and R&D efficiency.

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