FDA.reportPublic FDA data

GN Hearing

Primary DI
05708296157167
Brand
GN Hearing
Company
Gn Hearing A/S
Model
20967575
Device description
HI,H961-DRW,CHMPN
Published
2020-07-13
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Unsafe

Contact Domains#

Product Codes#

Code, Name table
CodeName
OSMHearing aid, air conduction with wireless technology

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OSMHearing Aid, Air-Conduction With Wireless Technology, PrescriptionEar, Nose, Throat2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05708296157167PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05708296157167057082961571675708296157167

GMDN Terms#

Term, Definition table
TermDefinition
Receiver-in-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 consists of a microphone and an amplifier in a case behind-the-ear (BTE) connected, via a wire, to a receiver (speaker) in the ear canal [receiver-in-canal (RIC)]. 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. 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

Contacts#

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

Regulatory Flags#

DUNS number
306179227
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
05708296456383GN Hearing242827002026-05-19
05708296456390GN Hearing242828002026-05-19
05708296458349GN Hearing242927002026-05-19
05708296473359GN Hearing242945002026-05-19
05708296382491GN ReSound236197002026-04-28
05708296434459GN Hearing239357002026-04-28
05708296434473GN Hearing239359002026-04-28
05708296434541GN Hearing239366002026-04-28
05708296434565GN Hearing239368002026-04-28
05708296435913GN Hearing240701002026-04-28
05708296435944GN Hearing240704002026-04-28
05708296435951GN Hearing240705002026-04-28
05708296435999GN Hearing240709002026-04-28
05708296436019GN Hearing240711002026-04-28
05708296436026GN Hearing240712002026-04-28
05708296436040GN Hearing240714002026-04-28
05708296436088GN Hearing240718002026-04-28
05708296436101GN Hearing240720002026-04-28
05708296436125GN Hearing240722002026-04-28
05708296390243GN Hearing237709002026-03-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07613389840599Moxi S9-RXSonova AGOSM2026-07-26
07613389840605Moxi S9-RXSonova AGOSM2026-07-26
07613389842012Moxi S7-RXSonova AGOSM2026-07-26
07613389842029Moxi S7-RXSonova AGOSM2026-07-26
07613389842036Moxi S7-RXSonova AGOSM2026-07-26
07613389842043Moxi S7-RXSonova AGOSM2026-07-26
07613389842050Moxi S7-RXSonova AGOSM2026-07-26
07613389842067Moxi S7-RXSonova AGOSM2026-07-26
07613389842074Moxi S9-RXSonova AGOSM2026-07-26
07613389842081Moxi S9-RXSonova AGOSM2026-07-26
07613389842098Moxi S9-RXSonova AGOSM2026-07-26
07613389842104Moxi S9-RXSonova AGOSM2026-07-26
07613389842111Moxi S-RX FLEX:TRIALSonova AGOSM2026-07-26
07613389843682Relate5.0 Platinum RIC RXSonova AGOSM2026-07-26
07613389843699Relate5.0 RIC RX DEMOSonova AGOSM2026-07-26
07613389844627Relate5.0 Gold RIC RXSonova AGOSM2026-07-26
07613389844634Relate5.0 Gold RIC RXSonova AGOSM2026-07-26
07613389844641Relate5.0 Gold RIC RXSonova AGOSM2026-07-26
07613389844658Relate5.0 Platinum RIC RXSonova AGOSM2026-07-26
07613389844665Relate5.0 Platinum RIC RXSonova AGOSM2026-07-26
07613389844955Unitron ChargerGo RIC S-RXSonova AGOSM2026-07-26
07613389844962Easy Line ChargerGo RIC S-RXSonova AGOSM2026-07-26
07613389844979Unitron ChargerGo RIC S-RXSonova AGOSM2026-07-26
07613389844986Unitron ChargerGo RIC S-RXSonova AGOSM2026-07-26
07613389844993Easy Line ChargerGo RIC S-RXSonova AGOSM2026-07-26
07613389845006Easy Line ChargerGo RIC S-RXSonova AGOSM2026-07-26
07613389867022Unitron TrueFit 5.10Sonova AGOSM2026-07-26
07613389867039Aura:fit AudioNova 5.10Sonova AGOSM2026-07-26
07613389867046Aura:fit 5.10Sonova AGOSM2026-07-26
07613389867053HANSATON scout 5.10Sonova AGOSM2026-07-26