Certified hearing apps, OTC hearing aids and tinnitus tools
15 hearing apps and devices, each checked against the FDA register, EUDAMED and the German DiGA directory. Last checked 18 October 2026.
Since the US created an over-the-counter category for hearing aids in 2022, hearing has changed fast. Self-fitting hearing aids, earbuds and even glasses and phone features are now cleared. For tinnitus, there is an authorised device and two reimbursed apps in Germany.
Below you find every hearing tool we track, grouped by what we could verify in the official registers.
In the US: FDA verified
Authorised by the FDA (510(k), De Novo or PMA), newest decisions first.
Jabra Enhance Select Self-fit 
Meta Hearing Assist - Samsung Hearing Aid Feature
Nuance Audio 
Tuned Self-Fitting App 
Concha Sol™ - Lenire®
Lexie B2 
Sontro® Self-Fitting OTC Hearing Aid
In the EU: CE class IIa or higher
Found in EUDAMED as class IIa or higher. We show whether a notified body certificate is visible there.
In Germany: DiGA
Listed in the German directory of reimbursed digital health applications.
Watchlist
These products are presented as certified, by their maker or in earlier directories, but we found no matching record in the official register, or they are no longer supported by their maker. Some are registered and listed with the FDA as exempt devices, which is legal but is not a clearance.
The trap to avoid
A clearance stays in the register when the company behind it disappears. Two cleared hearing products, Eargo and Nuheara, are on our watchlist because their makers have stopped or wound down. Before you recommend a hearing device, check that the maker still supports it.
Questions
What is an over-the-counter hearing aid?
A hearing aid for adults with perceived mild to moderate hearing loss, sold without a prescription in the US. In our directory, Jabra Enhance Select, Lexie B2, Sontro, Concha Sol and the Tuned app hold 510(k) clearances.
Can earbuds or glasses be hearing aids?
Yes, when cleared as such. In our directory, Nuance Audio glasses (2025), the Samsung Hearing Aid Feature (2026) and Meta Hearing Assist (2026) hold 510(k) clearances.
Is there an authorised treatment for tinnitus?
Lenire, which combines sound with tongue stimulation, was authorised through the De Novo route in 2023. In Germany, Kalmeda Tinnitus and Meine Tinnitus App are listed as DiGA.
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