Implant, Hearing, Active, Middle Ear, Totally Implanted

OAF · Class III — High Risk (PMA approval required, life-sustaining) · Unknown

Classification

FDA Product Code: OAF
Device class: Class III — High Risk (PMA approval required, life-sustaining)
Regulation: —
Review panel: EN
Medical specialty: Unknown
Submission type: 2
GMP exempt: N
Life sustaining: N
Implant: Y
Third-party review: N

Definition

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%.

Market data

Cleared 510(k) submissions: 0
Registered establishments: 4

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown