Product code QUF

Device name

Hearing Aid, Air-Conduction, Over The Counter

Medical specialty

Ear, Nose, Throat

Device class

1

Regulation number

874.3300

Review panel

EN

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Ineligible

Definition

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 an over the counter hearing aid. For information on the final rule “Establishing Over-the-Counter Hearing Aids,” please see 87 FR 50698, available at https://www.govinfo.gov/content/pkg/FR-2022-08-17/pdf/2022-17230.pdf.

Source

FDA openFDA device classification dataset