← FDA DEVICE PRODUCT CODES

FDA PRODUCT CODE · CLASS III

OAF — Implant, Hearing, Active, Middle Ear, Totally Implanted

Intended to provide useful hearing to persons with sensorineural hearing loss. Indicated for adults with mild to severe sensorineural hearing loss who have a speech discrimination score greater than or equal to 60%.

DEVICE CLASS
Class III
MEDICAL SPECIALTY
Unknown
REVIEW PANEL
EN
✓ Implant— Life-sustaining— GMP-exempt— Third-party review eligible
1
510(K)/PMA CLEARANCES
pma: 1
0
RECALL ENTRIES

Recent clearances

P090018Envoy Medical Corporation · pma2026-06-03

Related on SPEQ

Medical devices industry →Medical device quality (ISO 13485) →FDA device clearances →FDA enforcement & recalls →

Source: FDA device classification, 510(k)/PMA, and recall datasets (openFDA). Recall entries count distinct FDA recall numbers, so one recall event affecting several products appears as several entries. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.

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