FDA.report

GN Hearing

Primary DI
05708296140640
Brand
GN Hearing
Company
Gn Hearing A/S
Model
20295100
Device description
EM,BTE-SFT-TN
Published
2016-09-22
Public version status
Update
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
05708296140640PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
05708296140640057082961406405708296140640

GMDN Terms

TermDefinition
Earmould, custom-madeA custom-made device designed to fit in an individual ear, made from an impression of that ear, and through which the acoustic output from a hearing aid is conveyed to the eardrum, or in which transducer components of a hearing aid are aligned. It is made of synthetic polymer materials. This is a reusable device.

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

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
07613389755763Phonak Audéo E50-RSonova AGOSM2026-03-17
07613389755770Phonak Audéo E30-RSonova AGOSM2026-03-17
07613389759112Phonak Audéo E90-Sphere Sonova AGOSM2026-03-17
07613389759129Phonak Audéo E70-Sphere Sonova AGOSM2026-03-17
07613389759136Phonak Audéo E50-Sphere Sonova AGOSM2026-03-17
07613389759150Phonak Audéo E-R Trial Sonova AGOSM2026-03-17
07613389759174Phonak Audéo ESphereTrial Sonova AGOSM2026-03-17
07613389761917Phonak Audéo E30-RSonova AGOSM2026-03-17
07613389761924Phonak Audéo E30-RSonova AGOSM2026-03-17
07613389761931Phonak Audéo E30-RSonova AGOSM2026-03-17
07613389761948Phonak Audéo E30-RSonova AGOSM2026-03-17
07613389761955Phonak Audéo E30-RSonova AGOSM2026-03-17
07613389761962Phonak Audéo E30-RSonova AGOSM2026-03-17
07613389761979Phonak Audéo E30-RSonova AGOSM2026-03-17
07613389761986Phonak Audéo E30-RSonova AGOSM2026-03-17
07613389761993Phonak Audéo E30-RSonova AGOSM2026-03-17
07613389762006Phonak Audéo E30-RSonova AGOSM2026-03-17
07613389762013Phonak Audéo E50-RSonova AGOSM2026-03-17
07613389762020Phonak Audéo E50-RSonova AGOSM2026-03-17
07613389762037Phonak Audéo E50-RSonova AGOSM2026-03-17
07613389762044Phonak Audéo E50-RSonova AGOSM2026-03-17
07613389762051Phonak Audéo E50-RSonova AGOSM2026-03-17
07613389762068Phonak Audéo E50-RSonova AGOSM2026-03-17
07613389762075Phonak Audéo E50-RSonova AGOSM2026-03-17
07613389762082Phonak Audéo E50-RSonova AGOSM2026-03-17
07613389762099Phonak Audéo E50-RSonova AGOSM2026-03-17
07613389762105Phonak Audéo E50-RSonova AGOSM2026-03-17
07613389762143Phonak Audéo E70-R Sonova AGOSM2026-03-17
07613389762150Phonak Audéo E70-R Sonova AGOSM2026-03-17
07613389762167Phonak Audéo E70-R Sonova AGOSM2026-03-17