510(k) K843144

K-BASS LO FREQUENCY HEARING AID by Etymotic Research — Product Code ESD

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: September 7, 1984
Date Received: August 10, 1984
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Hearing Aid, Air-Conduction, Prescription
Device Class: Class I
Regulation Number: 874.3300
Review Panel: EN
Submission Type

An air-conduction hearing aid is a wearable sound amplifying device intended to compensate for impaired hearing that conducts sound to the ear through the air. This is a prescription hearing aid.

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