FDA.reportPublic FDA data

GN ReSound

Primary DI
05708296073412
Brand
GN ReSound
Company
Gn Hearing A/S
Model
20391900
Device description
PKG ASM,13,L,LHT,FL9MIH-MP
Published
2018-05-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
false
OTC
false
Sterile
false
Single use
false

Contact Domains#

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
05708296073412PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05708296073412057082960734125708296073412

GMDN Terms#

Term, Definition table
TermDefinition
Canal air-conduction hearing aidA 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 miniature microphone, amplifier, and speaker (receiver) in a case that fits the ear canal [in-the-canal (ITC)] or in a case nearly hidden in the ear canal [completely-in-the-canal (CIC)]. 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. It is used for mild to moderately-severe hearing loss; most types are programmable to enable computerized adjustments for a patient's hearing loss and related factors.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1-888-735-4327consumerhelp@gnresound.com

Regulatory Flags#

DUNS number
306179227
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05708296390243GN Hearing237709002026-03-05
05708296390328GN Hearing237717002026-03-05
05708296390410GN Hearing237726002026-03-05
05708296429073GN HearingJEC1CIC-HP2026-03-05
05708296429080GN HearingJEC1CIC-LP2026-03-05
05708296429097GN HearingJEC1CIC-MP2026-03-05
05708296429103GN HearingJEC1ITC-C-HP2026-03-05
05708296429110GN HearingJEC1ITC-C-LP2026-03-05
05708296429127GN HearingJEC1ITC-C-MP2026-03-05
05708296429134GN HearingJEC1ITC-C-UP2026-03-05
05708296429141GN HearingJEC1ITC-HP2026-03-05
05708296429158GN HearingJEC1ITC-LP2026-03-05
05708296429165GN HearingJEC1ITC-MP2026-03-05
05708296429172GN HearingJEC1ITC-UP2026-03-05
05708296429189GN HearingJEC1ITE-C-HP2026-03-05
05708296429196GN HearingJEC1ITE-C-MP2026-03-05
05708296429202GN HearingJEC1ITE-C-UP2026-03-05
05708296382927BeltoneILU17CIC-HP2026-02-10
05708296382934BeltoneILU17CIC-LP2026-02-10
05708296382941BeltoneILU17CIC-MP2026-02-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05714464148103PhilipsSbo 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
05714464148271OticonSbo Hearing A/SLRB2025-02-10
05714464148295BernafonSbo Hearing A/SLRB2025-02-10
05714464148325BernafonSbo Hearing A/SLRB2025-02-10
05714464148332BernafonSbo Hearing A/SLRB2025-02-10
05714464148349BernafonSbo Hearing A/SLRB2025-02-10
05714464148363PhilipsSbo Hearing A/SLRB2025-02-10
05714464148370PhilipsSbo Hearing A/SLRB2025-02-10
05714464148431PhilipsSbo Hearing A/SLRB2025-02-10
05714464148837AGXOSbo Hearing A/SLRB2025-02-10
05714464148851AGXOSbo Hearing A/SLRB2025-02-10
05714464148875AGXOSbo Hearing A/SLRB2025-02-10
05714464148899AGXOSbo Hearing A/SLRB2025-02-10
05714464158911OticonSbo Hearing A/SLRB2025-02-10
05714464158935OticonSbo Hearing A/SLRB2025-02-10
05714464158973OticonSbo Hearing A/SLRB2025-02-10
05714464158980BernafonSbo Hearing A/SLRB2025-02-10
05714464158997BernafonSbo Hearing A/SLRB2025-02-10
05714464159024BernafonSbo Hearing A/SLRB2025-02-10
05714464159031BernafonSbo Hearing A/SLRB2025-02-10
05714464159086PhilipsSbo Hearing A/SLRB2025-02-10
05714464159093PhilipsSbo Hearing A/SLRB2025-02-10
05714464159109PhilipsSbo Hearing A/SLRB2025-02-10
05714464159116PhilipsSbo Hearing A/SLRB2025-02-10