By brand

Otofonix

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.

FDA regulatory pathways in this brand

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.

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Available products

Sorted by price (low to high). All pricing verified June 2026.

Otofonix

Elite

Personal Sound Amplifier — NOT a hearing aid
Severity range
2640 dB HL
Form factor
BTE
Battery
Disposable
Bluetooth
No
Trial
45 days
Warranty
12 months

PSAP — NOT an FDA-cleared hearing aid. Entry-tier Otofonix on disposable batteries.

Affiliate disclosure: we may earn a commission if you purchase through these links, at no extra cost to you.

Otofonix

Sona

Personal Sound Amplifier — NOT a hearing aid
Severity range
2640 dB HL
Form factor
RIC
Battery
Rechargeable
Bluetooth
App control
Trial
45 days
Warranty
12 months

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.

Affiliate disclosure: we may earn a commission if you purchase through these links, at no extra cost to you.

Otofonix

Helix

Personal Sound Amplifier — NOT a hearing aid
Severity range
2640 dB HL
Form factor
BTE
Battery
Rechargeable
Bluetooth
No
Trial
45 days
Warranty
12 months

PSAP — NOT an FDA-cleared hearing aid. Zero 510(k) under Otofonix in openFDA. Marketed as 'FDA-registered Class I' which is establishment-only.

Affiliate disclosure: we may earn a commission if you purchase through these links, at no extra cost to you.

Other ways to find your hearing aid

Run your audiogram through the interpreter for personalized device-class + product matches. Identify your Costco Kirkland if you already own one. Browse by severity if you know your PTA.

Last reviewed June 2026. HearingAidMatch is not affiliated with Otofonix. Regulatory pathway labels per openFDA classification database. Affiliate-eligible products may pay us a commission if you purchase through this page.
Personal Sound Amplifier (PSAP) — NOT an FDA-cleared hearing aid. PSAPs are regulated as consumer audio products, not medical devices.