FDA.reportPublic FDA data

GN ReSound

Primary DI
05708296077823
Brand
GN ReSound
Company
Gn Hearing A/S
Model
20436500
Device description
SFP,312,FXD,L,LHT,GF30-DW MP
Published
2018-04-18
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
05708296077823PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05708296077823057082960778235708296077823

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
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
05714464167012BirdsongSbo Hearing A/SLRB2026-03-26
05714464167029BirdsongSbo Hearing A/SLRB2026-03-26
05714464167036BirdsongSbo Hearing A/SLRB2026-03-26
05714464167043BirdsongSbo Hearing A/SLRB2026-03-26
05714464167050BirdsongSbo Hearing A/SLRB2026-03-26
05714464167067BirdsongSbo Hearing A/SLRB2026-03-26
05714464167074BirdsongSbo Hearing A/SLRB2026-03-26
05714464167081BirdsongSbo Hearing A/SLRB2026-03-26
05714464167098BirdsongSbo Hearing A/SLRB2026-03-26
05714464167104BirdsongSbo Hearing A/SLRB2026-03-26
05714464167111BirdsongSbo Hearing A/SLRB2026-03-26
05714464167128BirdsongSbo Hearing A/SLRB2026-03-26
05714464167135BirdsongSbo Hearing A/SLRB2026-03-26
05714464167142BirdsongSbo Hearing A/SLRB2026-03-26
05714464167159BirdsongSbo Hearing A/SLRB2026-03-26
05714464148103PhilipsSbo Hearing A/SLRB2025-02-10
05714464148110PhilipsSbo 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
05714464148264OticonSbo Hearing A/SLRB2025-02-10
05714464148271OticonSbo Hearing A/SLRB2025-02-10
05714464148288BernafonSbo Hearing A/SLRB2025-02-10
05714464148295BernafonSbo Hearing A/SLRB2025-02-10
05714464148301BernafonSbo Hearing A/SLRB2025-02-10
05714464148318BernafonSbo Hearing A/SLRB2025-02-10
05714464148325BernafonSbo Hearing A/SLRB2025-02-10