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.”
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.
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 As hoped, the FDA also issued an updated draft guidance, “Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products (PSAPs).”
California Attorney General Rob Bonta issued a consumer alert warning Californians to exercise caution when purchasing direct-to-consumer hearing products, such as hearing aids, over-the-counter or online.
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In an article discussing the future of hearables, “Forbes” writer Frank Fitzpatrick ponders the future of the market once the FDA releases its guidelines for OTC hearing aids.
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Sycle hosted the webinar, “Over the Counter (OTC) Hearing Aids: Their Impact on the Marketplace,” featuring Kyle Acker (RiseENT), Matt Dearing (My Hearing Centers), Bill Brownie (Eargo), Karl Strom (Hearing Review), and moderated by Sean Shoffstall (Sycle). The webinar is now available for viewing on-demand.
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Eargo 5 is Eargo’s fifth-generation device and is a medical-grade, FDA Class II exempt hearing device designed to be “customizable by the user to their hearing preferences through all new Sound Match technology,” according to Eargo’s announcement. Through Sound Match, Eargo 5 “helps enable custom tuning with no clinic visits or waiting rooms.”
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During its annual Worldwide Developers Conference (WWDC) on June 7, Apple announced new speech-in-noise enhancement capabilities in iOS 15 called “Conversation Boost,” which uses computational audio and beamforming microphones for use in Apple AirPod Pros.
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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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GN announced the launch of Jabra Enhance Pro, “a new, premium hearing aid line-up” to be launched in more than 700 Costco Hearing Aid Centers around the world. This solution “makes it easier for people to take action and tackle the challenges of hearing loss,” according to GN’s announcement.
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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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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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Bose Corp has announced the launch of its SoundControl Hearing Aids, the first FDA-cleared self-fitting hearing aids.
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With the current round and cumulative $20M in lifetime funding, Olive says it “plans to expand beyond its existing hearing aids product line into new digital therapeutics for tinnitus and overall hearing health, and begin laying the foundation for its next generation of smart hearing technology.”
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With the rise of telecare and DIY/self-fit hearing devices (for at least milder hearing losses), hearing healthcare stakeholders will need to determine how and in what markets they do business.
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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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Unlike conventional hearing aids, Earlens “doesn’t amplify sound with a speaker but, instead, it directly stimulates the eardrum.”
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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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