Details checkedStatus confirmedCheckedcompany

Soundwave Sontro Self-Fitting OTC Hearing Aids

Also known as: Soundwave Sontro, Sontro OTC Hearing Aids, Sontro Model AI-S, Sontro Model AI, otoTune app, Sontro Self-Fitting OTC Hearing Aids

Soundwave Hearing

Primary source

Company

Soundwave Hearing

Program Type

Device

Modality

OTC Hearing Aid

Stage

Marketed

Status

Marketed

Target Gene

—

Route / Mode

Self-fitting OTC receiver-in-canal hearing aids plus otoTune mobile app

Confidence

84%

Status Confidence

Status confirmed

Evidence Strength

Needs more support

Last Reviewed

2026-06-10

Geography

United States

Population

adult, mild-to-moderate, otc, self-fitting, app-personalized

Trial IDs

Mechanism

Self-fitting OTC receiver-in-canal hearing aids paired with the otoTune app, using an in-situ hearing test and app-driven personalization, with AI-S streaming variants adding Bluetooth phone-call and audio streaming.

Indications

Hearing Loss

Notes

Adds an early self-fitting OTC platform with app-based in-situ fitting. The company storefront was not a normal live catalog page in this pass, so this stays Tier 3 despite marketed/regulatory-backed evidence from company announcements, app listings, and specialty coverage.

Evidence & Sources

3 structured sources

company

Supports: canonicalName, aliases, company, mechanism, status, route, populationTags, keyEvents

IDs: Sontro Self-Fitting OTC Hearing Aids, otoTune

Open

publication

Supports: aliases, mechanism, notes, status

IDs: Sontro Model AI-S

Open

database

Supports: aliases, mechanism, route