FDA.reportPublic FDA data

Retone

Primary DI
06974308960134
Brand
Retone
Company
Xiamen Retone Hearing Technology Co., Ltd
Model
clear 100 ITC
Published
2025-01-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Product Codes#

Code, Name table
CodeName
LRBFace Plate Hearing Aid

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LRBFace Plate Hearing AidEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06974308960134PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06974308960134069743089601346974308960134

GMDN Terms#

Term, Definition table
TermDefinition
Air-conduction hearing aid, behind-the-earA battery-powered acoustic device intended to compensate for impaired hearing by transmitting amplified sound waves to the eardrum through air. It typically consists of a microphone, an amplifier, and a speaker (receiver) contained in a case worn behind-the-ear (BTE). The microphone receives sound waves and converts them into electrical signals which are increased by the amplifier and sent as sound waves, by the speaker, to the eardrum through an earmould that fits inside the outer ear or a tube in the ear canal. The device is used for mild to profound hearing loss; most types are programmable to enable computerized adjustments for a patient's hearing loss and related factors.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
544329913
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
16974308960209Retone, NebrooK1605BE2026-02-05
16974308960193Retone Smart 1604LE2026-01-08
16974308960186Retone, NebrooK159RC2025-09-10
16974308960179Retone, NebrooK1625BE2025-04-17
16974308960162Retone Bro 102S2025-02-06
06974308960004Retone K2182025-01-24
06974308960011Retone K218P2025-01-24
06974308960028Retone Clear 2162025-01-24
06974308960035Retone Vigor 4022025-01-24
06974308960042Retone Vigor 402BT2025-01-24
06974308960059Retone Vigor 4032025-01-24
06974308960066Retone Vigor 403BT2025-01-24
06974308960073Retone K218SP2025-01-24
06974308960080Retone Vigor 402BT-P2025-01-24
06974308960097Retone Vigor U 4022025-01-24
06974308960103Retone Vigor U 402BT2025-01-24
06974308960110Retone Vigor U 4032025-01-24
06974308960127Retone Vigor U 403BT2025-01-24
06974308960141Retone clear 400BT CIC2025-01-24
06974308960158Retone Eggo 2022025-01-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05714464167012BirdsongSbo Hearing A/SLRB2026-03-26
05714464167029BirdsongSbo Hearing A/SLRB2026-03-26
05714464167036BirdsongSbo Hearing A/SLRB2026-03-26
05714464167043BirdsongSbo Hearing A/SLRB2026-03-26
05714464167050BirdsongSbo Hearing A/SLRB2026-03-26
05714464167067BirdsongSbo Hearing A/SLRB2026-03-26
05714464167074BirdsongSbo Hearing A/SLRB2026-03-26
05714464167081BirdsongSbo Hearing A/SLRB2026-03-26
05714464167098BirdsongSbo Hearing A/SLRB2026-03-26
05714464167104BirdsongSbo Hearing A/SLRB2026-03-26
05714464167111BirdsongSbo Hearing A/SLRB2026-03-26
05714464167128BirdsongSbo Hearing A/SLRB2026-03-26
05714464167135BirdsongSbo Hearing A/SLRB2026-03-26
05714464167142BirdsongSbo Hearing A/SLRB2026-03-26
05714464167159BirdsongSbo Hearing A/SLRB2026-03-26
05714464148103PhilipsSbo Hearing A/SLRB2025-02-10
05714464148110PhilipsSbo Hearing A/SLRB2025-02-10
05714464148202OticonSbo Hearing A/SLRB2025-02-10
05714464148219OticonSbo Hearing A/SLRB2025-02-10
05714464148226OticonSbo Hearing A/SLRB2025-02-10
05714464148233OticonSbo Hearing A/SLRB2025-02-10
05714464148240OticonSbo Hearing A/SLRB2025-02-10
05714464148257OticonSbo Hearing A/SLRB2025-02-10
05714464148264OticonSbo Hearing A/SLRB2025-02-10
05714464148271OticonSbo Hearing A/SLRB2025-02-10
05714464148288BernafonSbo Hearing A/SLRB2025-02-10
05714464148295BernafonSbo Hearing A/SLRB2025-02-10
05714464148301BernafonSbo Hearing A/SLRB2025-02-10
05714464148318BernafonSbo Hearing A/SLRB2025-02-10
05714464148325BernafonSbo Hearing A/SLRB2025-02-10