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USound MEMS Speakers for Hearables and Wearables

USound, a provider of micro-electro-mechanical systems (MEMS) loudspeakers for hearables and wearables, announced that it “is on a rapid path to replacing balanced armature microspeakers with MEMS speakers in most portable consumer electronics by 2025.”

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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.

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 As hoped, the FDA also issued an updated draft guidance, “Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products (PSAPs).”

Comparing Population Coverage between Hearing Aids Using Presets vs Bose CustomTune

The self-fitting Bose SoundControl™ hearing aid is the first of its kind to gain FDA clearance. In the self-fitting process, the Bose Hear app uses the Bose CustomTune™ interface for mapping to a wide range of target gain profiles, derived from a hearing loss database. This article compares the population coverage—or the percentage of people who would be able to find a frequency gain profile similar to a NAL-NL2 prescription fit—of SoundControl to other self-fitting amplification devices which typically feature only 1 to 4 preset gain profiles.

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Comparing Population Coverage between Hearing Aids Using Presets vs Bose CustomTune™

The self-fitting Bose SoundControl™ hearing aid is the first of its kind to gain FDA clearance. In the self-fitting process, the Bose Hear app uses the Bose CustomTune™ interface for mapping to a wide range of target gain profiles, derived from a hearing loss database. This article compares the population coverage—or the percentage of people who would be able to find a frequency gain profile similar to a NAL-NL2 prescription fit—of SoundControl to other self-fitting amplification devices which typically feature only 1 to 4 preset gain profiles.

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Now at Some Walgreens: Lexie Hearing Aids

Lexie Lumen hearing aids will soon be available directly for sale in hundreds of Walgreens stores in Arizona, Colorado, North Carolina, Tennessee, and Texas. Lexie Hearing is a subscription service designed to provide consumers with hearing aids, accessories, and access to hearing experts for a monthly fee.

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Nuheara Receives FDA Registration for IQbuds2 Pro

The IQbuds² PRO has received FDA classification as a Class 2 medical device. “Utilizing Nuheara’s connected hearing technology platform, the company’s aspiration is to create an end-to-end hearing healthcare company by efficiently delivering hearing products, accessories, and services across the Hearables, Medical Device, and OTC markets,” says Nuheara CEO Justin Miller.

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Nuheara IQbuds2 Max Selected for ‘TIME’s 2020 Best Inventions’

According to Nuheara, what makes IQbuds² MAX unique is the EarID clinically certified personalization system embedded in the IQbuds App. EarID helps allow consumers “to self-assess, self-fit, and auto calibrate their IQbuds² MAX to their own personal hearing profile using National Acoustic Labs NAL-NL2 hearing aid prescription algorithms.”

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