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Details checkedStrong evidenceCheckedregulatory

Cochlear Nucleus ABI541 Brainstem Implant

Also known as: Nucleus ABI541, ABI541, Nucleus auditory brainstem implant

Cochlear

Primary source
Company
Cochlear
Program Type
Device
Modality
BCI/Neurotech
Stage
Approved
Status
Approved
Target Gene
—
Route / Mode
Implantable neuroprosthetic device with external sound processor
Confidence
95%
Status Confidence
Status confirmed
Evidence Strength
Strong evidence
Last Reviewed
2026-05-31
Geography
United States, selected global markets
Population
adult, post-lingual, profound
Trial IDs
0
Mechanism

A neuroprosthetic implant that restores a level of auditory sensation by electrically stimulating the cochlear nucleus in the brainstem.

Indications
Hearing LossAuditory Neuropathy
Notes

Niche but strategically important neuroprosthetic platform for patients not served by cochlear implants, especially NF2-related cases with nonfunctional auditory nerves.

Evidence & Sources
2 structured sources
regulatory
Supports: canonicalName, company, modality, mechanism, indications, stage, status, populationTags
IDs: P000015S012
Open
company
Supports: aliases, route, notes, geography
Open
Key Events
2000-10-24
FDA approved the Nucleus ABI541 Auditory Brainstem Implant supplement
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