Tympanic Membrane Direct Contact Hearing Aid

PLK · Class II — Moderate Risk (510(k) clearance required) · Ear, Nose, Throat · 21 CFR 874.3315

Classification

FDA Product Code: PLK
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 874.3315
Review panel: EN
Medical specialty: Ear, Nose, Throat
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: Y
Third-party review: N

Definition

A tympanic membrane contact hearing aid is intended to compensate for impaired hearing by transmitting amplified sound by vibrating the tympanic membrane through a transducer that is in direct contact with the tympanic membrane.

Market data

Cleared 510(k) submissions: 3
Registered establishments: 1

Source

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