Announcements

Audio-Technica announced the Mimio Assist One earbuds and a matching TV speaker, designed for people who want occasional hearing help. These are Personal Sound Amplification Products (PSAPs), consumer devices that make sounds louder but aren’t regulated as medical hearing aids. They can be used by people without diagnosed hearing loss who just want clearer sound in situations like watching TV,…

The FDA’s August 4, 2025 update to the Accredited Persons list shows eight organizations currently recognized to conduct third-party 510(k) reviews for select medical devices, including hearing aids. This allows eligible devices to be reviewed by accredited organizations rather than FDA staff, potentially reducing clearance timelines. Authorized third party reviewers includes Regulatory Technology…

Envoy Medical announced that its pivotal clinical trial for the fully implanted Acclaim® Cochlear Implant is progressing on schedule, with all 10 participants in the first stage successfully completing their one-month follow-up visits. No serious adverse events or unexpected device issues have been reported so far, which supports the initial safety profile of the implant. The Acclaim is designed…

Apple’s AirPods Pro 2 are now FDA-approved as over-the-counter hearing aids for adults with mild to moderate hearing loss. Users can take a hearing test on their iPhone or iPad (iOS 18+) and activate personalized sound settings. With a software update, users will be able to access hearing aid features without needing a prescription or audiologist visit. This change could make hearing support more…

Cochlear Limited has introduced the Baha 7 Sound Processor, the first bone-anchored device to ship with native Bluetooth LE Audio and Auracast broadcast streaming. The 55 dB HL fitting range sits inside a small housing that comes in seven colors. Cochlear reports that users can stream with compatible Apple or Android phones and pair with next-generation wireless accessories for richer, low-latency…

Are you 65 or older? Have you had any experience with medical device clinical studies over the past 5 years? If so, the FDA's Center for Devices and Radiological Health (CDRH) is looking for individuals to share their experiences during a virtual town hall for CDRH employees! The town hall will take place on Thursday, September 4, 2025, 11am - 1 pm EST. What’s this event about? The FDA wants to…

Bluetooth has released several case studies highlighting how Auracast, its new broadcast audio feature built on Bluetooth LE Audio, is being used in real-world settings. Auracast is intended to improve audio accessibility and user experience by offering clearer sound, simplified installation, and more flexible use compared to older systems like hearing loops. Examples of deployments include the…

Medicare is updating how it bills for hearing aid-related services by introducing 12 new billing codes starting January 1, 2026. These new codes replace outdated ones from 1993 and are designed to better reflect the full range of services audiologists provide today, including evaluation, device selection, fitting, and follow-up care. The update aims to make the billing process clearer and more…

Stadium Taranaki in New Zealand upgraded its audio system using Auracast , a new Bluetooth technology that streams live audio directly to hearing aids, earbuds, or phones. This gives fans with hearing loss a much better experience without needing special hardware or wired systems. Instead of installing complex hearing loops, the stadium uses Auracast-enabled transmitters to broadcast across key…

LG’s 2025 OLED and select QNED TVs now support Auracast, a feature built on Bluetooth LE Audio that allows multiple headphones or hearing aids to connect at once. This gives users more flexibility, such as watching TV with wireless earbuds, improving audio clarity, or sharing sound with others without sync issues. The feature isn’t mentioned clearly on LG’s product pages and is only listed under…