Details checkedStatus needs checkingCheckedregulatory

Ototronix MAXUM System

Also known as: MAXUM, Maxum System, Ototronix Maxum Middle Ear Implant

Ototronix

Primary source

Company

Ototronix

Program Type

Device

Modality

Bone Conduction / Middle-Ear Device

Stage

Approved

Status

Unknown

Target Gene

—

Route / Mode

Partially implantable active middle-ear hearing system

Confidence

82%

Status Confidence

Status needs checking

Evidence Strength

Needs more support

Last Reviewed

2026-06-10

Geography

United States

Population

adult, middle-ear-implant, active-implant, specialty-surgery

Trial IDs

Mechanism

Implantable middle-ear hearing system derived from Soundtec Direct System technology, using an ossicular implant and external processor to mechanically drive the ossicular chain for moderate to severe sensorineural hearing loss.

Indications

Hearing Loss Sensorineural Hearing Loss

Notes

Regulatory-backed active middle-ear implant record. Kept with unknown current commercial status because FDA PMA history verifies approval, but current product availability is not clearly demonstrated in public company sources.

Evidence & Sources

2 structured sources

regulatory

Supports: canonicalName, company, stage, status, geography

IDs: P010023

Open

regulatory

Supports: mechanism, indications, route

IDs: P010023

Open

Key Events

2010-08-16