Details checkedStrong evidenceCheckedregulatory

MED-EL ADHEAR System

Also known as: ADHEAR, ADHEAR audio processor, MED-EL ADHEAR bone conduction system

MED-EL

Primary source

Company

MED-EL

Program Type

Device

Modality

Bone Conduction / Middle-Ear Device

Stage

Marketed

Status

Marketed

Target Gene

—

Route / Mode

Adhesive non-surgical bone-conduction audio processor and skin adapter

Confidence

92%

Status Confidence

Status confirmed

Evidence Strength

Strong evidence

Last Reviewed

2026-06-10

Geography

United States, Europe, Global

Population

adult, pediatric, non-surgical-bone-conduction, single-sided-deafness

Trial IDs

Mechanism

Non-surgical adhesive bone-conduction hearing system using an adhesive adapter and external audio processor to transmit sound vibrations through bone without implantation or sustained pressure.

Indications

Hearing Loss Conductive Hearing Loss Mixed Hearing Loss Single-Sided Deafness

Notes

Adds the adhesive non-surgical bone-conduction branch, distinct from implanted systems such as Baha, Osia, BONEBRIDGE, Ponto, and Sentio.

Evidence & Sources

2 structured sources

company

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

Open

regulatory

Supports: aliases, indications, stage, geography

IDs: K172418

Open

Key Events

2017-10-12

FDA 510(k) clearance letter issued for the ADHEAR bone conduction system

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