510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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ESDClass I

Hearing Aid, Air-Conduction, Prescription

21 CFR 874.3300 / Ear, Nose, Throat
FDA source (opens on fda.gov)

ESD is the FDA product code for Hearing Aid, Air-Conduction, Prescription, a class I device type, regulated under 21 CFR 874.3300. FDA's definition for this code reads: "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". As of , FDA records hold 1,367 510(k) clearances under this code, the most recent dated , and 4 recalls.

Classification record

Product code
ESD
Device name
Hearing Aid, Air-Conduction, Prescription
FDA 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 a prescription hearing aid.
Regulation
21 CFR 874.3300
Device class
Class I
Review panel
Ear, Nose, Throat
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
1,367
Ingested recalls
4

Clearances, product code ESD

By decision year
1,367 clearances under product code ESD with a decision year between 1976 and 2024, 1994 the highest year at 113.
Show the numbers
510(k) clearances under FDA product code ESD by decision year
YearClearances
19768
197717
197838
197948
198051
198132
198249
198345
198441
198572
198654
198768
198853
198941
199095
199194
199280
199392
1994113
1995106
199682
199779
19983
19991
20011
20021
20081
20131
20241

Applicants with the most clearances

Product code ESD
Applicants holding the most 510(k) clearances under product code ESD
ApplicantClearances
Unitron Industries, Inc.69
Miracle-Ear, Inc.64
Oticon, Inc.64
Electone, Inc.63
Widex Hearing Aid Co., Inc.51
Rion Acoustic Instruments, Inc.47
Starkey Laboratories, Inc.39
Telex Communications, Inc.39
Phonak, Inc.37
Beltone Electronics Corp.36

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 99 companies shown, in name order