ESD · Class I · 21 CFR 874.3300

FDA Product Code ESD: Hearing Aid, Air-conduction, Prescription

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.

Leading manufacturers include 3M Company, Sonova AG and Zimmer, Inc..

1367

Total

1367

Cleared

56d

Avg days

1976

Since

Declining activity - 0 submissions in the last 2 years vs 1 in the prior period

FDA 510(k) Cleared Hearing Aid, Air-conduction, Prescription Devices (Product Code ESD)

1367 devices

1–24 of 1367

1 2 3 4

Cleared Apr 11, 2024

Lyric4 Hearing Aid

Ear, Nose, Throat · 202d

Cleared Sep 28, 1995

Ear, Nose, Throat · 29d

Cleared Aug 23, 1995

3M MODEL 8200P MULTIPRO BTE

Ear, Nose, Throat · 26d

Cleared Jan 24, 1995

3M MODEL 8233 HEARING INSTRUMENT

Ear, Nose, Throat · 169d

Cleared Dec 15, 1993

8260 SERIES 3M PROGRAMMABLE HEARING INSTRUMENTS

Ear, Nose, Throat · 51d

Cleared Oct 18, 1991

MODEL 80 HEARING AID DISPENSING SYSTEM

Ear, Nose, Throat · 88d

Cleared Apr 03, 1991

RESORBABLE BONE PLUG

Ear, Nose, Throat · 100d

Cleared Mar 13, 1991

3M MODEL 8240 ITE HEARING AID

Ear, Nose, Throat · 22d

Cleared Feb 28, 1991

3M MODEL 8241 ITE HEARING AID

Ear, Nose, Throat · 9d

Cleared Feb 28, 1991

3M MODEL 8242 ITE HEARING AID

Ear, Nose, Throat · 9d

Cleared Feb 28, 1991

3M MODEL 8243 ITE HEARING AID

Ear, Nose, Throat · 9d

Cleared Feb 28, 1991

3M MODEL 8244 ITE HEARING AID

Ear, Nose, Throat · 9d

Cleared Feb 28, 1991

3M MODEL 8245 ITE HEARING AID

Ear, Nose, Throat · 9d

Cleared Dec 28, 1990

MEMORYMATE MODEL 8270 ITE HEARING AID

Ear, Nose, Throat · 22d

Cleared Dec 17, 1990

MEMORYMATE HEARING AID WITH PMC PROGRAMMER

Ear, Nose, Throat · 109d

Cleared Oct 24, 1989

3M INSTANT FIT CUSTOM EARMOLD

Ear, Nose, Throat · 69d

Cleared Mar 09, 1988

MEMORYMATE HEARING AID MODEL 8200

Ear, Nose, Throat · 57d

Cleared Mar 30, 1987

3M INSTANT FIT CUSTOM EARMOLD

Ear, Nose, Throat · 19d

1 2 3 4

About Product Code ESD - Regulatory Context

510(k) Submission Activity

1367 total 510(k) submissions under product code ESD since 1976, with 1367 receiving FDA clearance (average review time: 56 days).

Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.

Related FDA 510(k) Regulatory Insights

Data Source

FDA 510(k) public files . 175,218 total devices indexed.

Latest clearance: Apr 11, 2024

Product Code Info

Code	ESD
Device class	Class I
CFR	21 CFR 874.3300
Panel	Ear, Nose, Throat

Verify on FDA.gov

View ESD classification on FDA.gov →