FDA.reportPublic FDA data

Oticon

Primary DI
05707131318251
Brand
Oticon
Company
Sbo Hearing A/S
Model
169232
Device description
REMOTE CONTROL 3.0, 2.4G BL HHM
Published
2019-12-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

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
05707131318251PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05707131318251057071313182515707131318251

GMDN Terms#

Term, Definition table
TermDefinition
Hearing device remote controlA battery-powered device designed to be operated by the wearer of a hearing aid or a hearing implant system to enable discreet wireless (remote) adjustments to the device (e.g., volume and program changes). It is designed to be conveniently portable (e.g., carried in a pocket, handbag, or attached to a key ring).

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+4539177100eand@demant.com

Regulatory Flags#

DUNS number
306018410
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05714464175659Maico2860902026-04-10
05714464175666Maico2860912026-04-10
05714464175673Maico2860922026-04-10
05714464175680Maico2860932026-04-10
05714464175697Maico2860942026-04-10
05714464175703Oticon2860952026-04-10
05714464175710Oticon2860962026-04-10
05714464175727Oticon2860972026-04-10
05714464175734Oticon2860982026-04-10
05714464175741Oticon2860992026-04-10
05714464175857Oticon2861102026-04-10
05714464175864Oticon2861112026-04-10
05714464175871Oticon2861122026-04-10
05714464175888Oticon2861132026-04-10
05714464175895Oticon2861142026-04-10
05714464175963Oticon2861212026-04-10
05714464176175Bernafon2861422026-04-10
05714464176182Bernafon2861432026-04-10
05714464176199Bernafon2861442026-04-10
05714464176205Bernafon2861452026-04-10

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