FDA.report

GN Otometrics A/S

Primary DI
05713315000331
Brand
GN Otometrics A/S
Company
Gn Otometrics A/S
Model
Hearing Instrument Programmer
Published
2016-09-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
ESDHearing Aid, Air Conduction

Product Code Classifications

CodeDeviceSpecialtyClass
ESDHearing Aid, Air-Conduction, PrescriptionEar, Nose, Throat1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
05713315000331PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
05713315000331057133150003315713315000331

GMDN Terms

TermDefinition
Wearable 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 microphone, an amplifier, and a speaker (receiver) contained in a case worn on the body (e.g., in a pocket or on a belt). 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 connected to the case by a cord. Because it's relatively large size permits high amplification, this device has been used for profound hearing loss; it has largely been replaced with behind-the-ear (BTE) devices.

Sterilization Methods

Method

Regulatory Flags

DUNS number
306633756
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
057133150107361091, ICS Dizcovery System8-04-164008-04-164002025-02-21
057133150108111091, ICS Dizcovery ShadeShift Panels 0456540456542025-02-21
057133150108281091, ICS Dizcovery LCD Panels0456520456522025-02-21
057133150108801091, ICS Dizcovery Universal Face Cushion (qty 40)0456570456572025-02-21
05713315007415MADSEN Astera 28-04-131278-04-131272024-12-12
05713315007439MADSEN Astera 28-04-131288-04-131282024-12-12
05713315007477MADSEN Astera 28-04-121188-04-121182024-12-12
05713315007521MADSEN Astera 28-04-131248-04-131242024-12-12
05713315007859MADSEN Astera 28-04-131048-04-131042024-12-12
05713315007132GN Otometrics A/SICS Impulse2024-12-04
05713315011054Otoscan0432440432442024-04-15
05713315008726Disposable Snap Electrodes (3 pack)8-64-210008-64-210002022-12-14
05713315008733Disposable Snap Electrodes (25 x 3 pack)8-64-218008-64-218002022-12-14
05713315010279Madsen A4508-04-14660 8-04-14660 2022-12-28
05713315010286Madsen A4508-04-14661 8-04-14661 2022-12-28
05713315010293Madsen A4508-04-14662 8-04-14662 2022-12-28
05713315009464Madsen Zodiac8-04-163078-04-163072022-12-05
05713315010699Otoscan0432430432432023-05-11
05713315009969Bone Conductor (BC-2)0415450415452023-03-09
05713315010101Bone Conductor (BC-2)0415460415462023-03-09

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
05708296429073GN HearingGn Hearing A/SESD2026-03-05
05708296429080GN HearingGn Hearing A/SESD2026-03-05
05708296429097GN HearingGn Hearing A/SESD2026-03-05
EDET030161medicalprint shell beige 2.0 1000gDETAX GmbHESD2026-02-25
00810068833218Lucid Hearing®HEARING LAB TECHNOLOGY, LLCESD2026-02-13
05708296382927BeltoneGn Hearing A/SESD2026-02-10
05708296382934BeltoneGn Hearing A/SESD2026-02-10
05708296382941BeltoneGn Hearing A/SESD2026-02-10
05708296383061BeltoneGn Hearing A/SESD2026-02-10
05708296383078BeltoneGn Hearing A/SESD2026-02-10
05708296383085BeltoneGn Hearing A/SESD2026-02-10
05708296383207BeltoneGn Hearing A/SESD2026-02-10
05708296383214BeltoneGn Hearing A/SESD2026-02-10
05708296383221BeltoneGn Hearing A/SESD2026-02-10
05708296383344BeltoneGn Hearing A/SESD2026-02-10
05708296383351BeltoneGn Hearing A/SESD2026-02-10
05708296383368BeltoneGn Hearing A/SESD2026-02-10
05708296383481GN ReSoundGn Hearing A/SESD2026-02-10
05708296383498GN ReSoundGn Hearing A/SESD2026-02-10
05708296383504GN ReSoundGn Hearing A/SESD2026-02-10
05708296383627GN ReSoundGn Hearing A/SESD2026-02-10
05708296383634GN ReSoundGn Hearing A/SESD2026-02-10
05708296383641GN ReSoundGn Hearing A/SESD2026-02-10
05708296383764GN ReSoundGn Hearing A/SESD2026-02-10
05708296383771GN ReSoundGn Hearing A/SESD2026-02-10
05708296383788GN ReSoundGn Hearing A/SESD2026-02-10
05708296383900GN ReSoundGn Hearing A/SESD2026-02-10
05708296383917GN ReSoundGn Hearing A/SESD2026-02-10
05708296383924GN ReSoundGn Hearing A/SESD2026-02-10
05708296384044GN HearingGn Hearing A/SESD2026-02-10