FDA.reportPublic FDA data

Beltone

Primary DI
05704819154972
Brand
Beltone
Company
Gn Hearing A/S
Model
15767100
Device description
SAT65, BEIGE
Published
2018-07-23
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
05704819154972PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05704819154972057048191549725704819154972

GMDN Terms#

Term, Definition table
TermDefinition
Contralateral hearing unitA passive (i.e., non-powered) acoustic device intended to compensate for total hearing loss in one ear, by transmitting sound received by a microphone from the deaf ear to an active (i.e., powered) hearing aid worn on the hearing ear. This contralateral routing of sound (CROS) technology is designed to improve awareness of sounds (e.g., traffic, speech) emanating from all directions. The device typically consists of a microphone contained in a case worn behind-the-ear (BTE) with a connection cable. The cable both transmits the power from, and the signal to, the active hearing aid.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1-888-235-8663marketing@beltoneapps.com

Regulatory Flags#

DUNS number
306179227
Device count
1
Premarket exempt
true
Lot or batch
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

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