FDA.report

GN Hearing

Primary DI
05708296137305
Brand
GN Hearing
Company
Gn Hearing A/S
Model
18157601
Device description
INTEGRD FM01 ADAPT NB,RS,NANO
Published
2018-07-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
OSMHearing aid, air conduction with wireless technology

Product Code Classifications

CodeDeviceSpecialtyClass
OSMHearing Aid, Air-Conduction With Wireless Technology, PrescriptionEar, Nose, Throat2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
05708296137305PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
05708296137305057082961373055708296137305

GMDN Terms

TermDefinition
Hearing aid enhanced audio device, teaching-environmentA collection of battery-powered devices designed to be worn by a person (typically a child) wearing a compatible hearing aid to enhance the sound quality they receive by reducing background noise and/or room reverberation potentially found in a teaching environment (e.g., a school classroom). It uses a set frequency modulation (FM) between a transmitter worn by the speaker (e.g., a microphone worn be the teacher) and the FM receiver worn by the user. It typically consists of the FM receiver, a neck induction loop that emits the sound locally to the hearing aid, a battery charger, and various cables enabling connection to digital music devices.

Sterilization Methods

Method

Contacts

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 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

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