By brand
3 products in our database · Average MSRP $348
Some Otofonix products are PSAPs, not FDA-cleared hearing aids.
Personal Sound Amplifiers (PSAPs) are regulated as consumer audio products, not medical devices. They're suitable for situational amplification (hunting, lecture halls), not for treating hearing loss. The PSAP-labeled Otofonix products below have a red banner; do not buy them as a hearing aid replacement. How to tell a PSAP from a real hearing aid →
Personal Sound Amplifier — NOT a hearing aid
Personal Sound Amplifier (PSAP) — NOT an FDA-cleared hearing aid. PSAPs are regulated as consumer audio products, not medical devices.
New to these labels? All 9 FDA pathways, decoded in plain English.
Sorted by price (low to high). All pricing verified July 2026.
Otofonix
PSAP — NOT an FDA-cleared hearing aid. Entry-tier Otofonix on disposable batteries.
Otofonix
Personal Sound Amplifier (PSAP) — NOT an FDA-cleared hearing aid. Zero 510(k) under Otofonix in openFDA; the brand markets as 'FDA-registered Class I' which is establishment registration only. PSAPs are regulated as consumer audio products and are appropriate for situational amplification (lectures, birdwatching, group dinners with normal hearing) but NOT for treating diagnosed hearing loss. If you have actual hearing loss, an FDA-cleared OTC self-fit hearing aid (QUH) — Lexie Lumen ($299) or Apple AirPods Pro 2 HAF ($199) — is similarly priced with rigorous regulatory backing.
Otofonix
PSAP — NOT an FDA-cleared hearing aid. Zero 510(k) under Otofonix in openFDA. Marketed as 'FDA-registered Class I' which is establishment-only.
Other ways to find your hearing aid
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