Details checkedStrong evidenceCheckedregulatory

Earlens Contact Hearing Solution

Also known as: Earlens, Earlens Contact Hearing Device, Earlens tympanic lens

Earlens Corporation

Primary source

Company

Earlens Corporation

Program Type

Device

Modality

Bone Conduction / Middle-Ear Device

Stage

Marketed

Status

Marketed

Target Gene

—

Route / Mode

Prescription contact hearing device with tympanic membrane lens and behind-the-ear processor

Confidence

91%

Status Confidence

Status confirmed

Evidence Strength

Strong evidence

Last Reviewed

2026-06-10

Geography

United States

Population

adult, clinical-audiology, middle-ear-assessment, tympanic-contact-device

Trial IDs

Mechanism

Light-driven contact hearing system using behind-the-ear processors and a custom tympanic membrane lens to directly vibrate the eardrum instead of only acoustically amplifying through the ear canal.

Indications

Hearing Loss Sensorineural Hearing Loss Conductive Hearing Loss Mixed Hearing Loss

Notes

Important non-implant middle-ear-adjacent hearing device because it uses a tympanic membrane lens to transmit sound mechanically rather than functioning as a conventional air-conduction hearing aid.

Evidence & Sources

2 structured sources

company

Supports: canonicalName, company, mechanism, status, route

Open

regulatory

Supports: indications, stage, geography

IDs: DEN150002

Open

Key Events

2015-09-29

FDA granted De Novo authorization for the Earlens Contact Hearing Device