FDA.reportPublic FDA data

Otofonix

Primary DI
06945936799045
Brand
Otofonix
Company
Xiamen New Sound Technology Co., Ltd.
Model
Groove
Published
2021-04-01
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

Product Codes#

Code, Name table
CodeName
QUGHearing Aid, Air-Conduction With Wireless Technology, Over The Counter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QUGHearing Aid, Air-Conduction With Wireless Technology, Over The CounterEar, Nose, Throat2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06945936799045PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06945936799045069459367990456945936799045

GMDN Terms#

Term, Definition table
TermDefinition
Air-conduction hearing aid, behind-the-earA 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 behind-the-ear (BTE). 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 that fits inside the outer ear or a tube in the ear canal. 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.

Regulatory Flags#

DUNS number
528181200
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
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
06945936701420NanoNano Sigma Beige2020-02-26
06945936701567OtofonixOtofonix Sona Beige2020-09-03
06945936703462VivtoneXpure2022-09-15
06945936703479VivtoneSmart2022-09-15
06945936703493NewSoundPrimo RA8012022-09-15
06945936703721NewsoundTactEar 8012023-11-17
06945936704063NanoFirst Ear Plus ITE2024-05-21
06945936704070NanoFirst Ear Plus BTE2024-05-21
06945936704087NanoFirst Ear Pro BTE2024-05-21
06945936703776NewsoundPrimo S2012024-01-19
06945936703714NewsoundPrimo SA4012023-11-17
06945936703394MDMDHearingAid VOLT2022-09-09
06945936703400NeosonicNeosonic MX-Smart2022-09-09
06945936703448NeosonicNeosonic BT-Omni2022-09-09
06945936703349NewSoundPoco XA6012022-09-08
06945936703363WENKEYWE-6012022-09-08
06945936703288NewsoundPOCO ZA4012022-09-05
06945936799106NewsoundHearIQ ITC2021-07-31
06945936799038OtofonixHelix2021-04-01
06945936799069InnerScope HearingHearIQ 42021-04-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06943786094839AUDIENAustar Hearing Science & Technology (Xiamen) Co., Ltd men) Co., Ltd.QUG2026-09-20
06977352080612ELEHEARELEHEAR Inc.QUG2026-09-05
06977352080629ELEHEARELEHEAR Inc.QUG2026-09-05
06977352080681ELEHEARELEHEAR Inc.QUG2026-09-05
06977352080698ELEHEARELEHEAR Inc.QUG2026-09-05
06974608620523PHONELUMShenzhen Eartech Co., Ltd.QUG2026-08-27
00850080488577flysoundShenzhen Flysounds Medical Technology Co.,Ltd.QUG2026-08-25
00850080488584flysoundShenzhen Flysounds Medical Technology Co.,Ltd.QUG2026-08-25
00850065321967CeretoneAudicon CorporationQUG2026-08-14
06943786094846AUSTARAustar Hearing Science & Technology (Xiamen) Co., Ltd men) Co., Ltd.QUG2026-08-14
08056262819890nuance audioLUXOTTICA GROUP SPAQUG2026-07-31
08056262856789nuance audioLUXOTTICA GROUP SPAQUG2026-07-31
06980305290013CEARVOLSHENZHEN CANNICE TECHNOLOGY CO.,LTDQUG2026-07-25
06980305290020CEARVOLSHENZHEN CANNICE TECHNOLOGY CO.,LTDQUG2026-07-25
06980305290037CEARVOLSHENZHEN CANNICE TECHNOLOGY CO.,LTDQUG2026-07-25
06980305290044CEARVOLSHENZHEN CANNICE TECHNOLOGY CO.,LTDQUG2026-07-25
06980305290068CEARVOLSHENZHEN CANNICE TECHNOLOGY CO.,LTDQUG2026-07-25
06980305290082CEARVOLSHENZHEN CANNICE TECHNOLOGY CO.,LTDQUG2026-07-25
06980305290099CEARVOLSHENZHEN CANNICE TECHNOLOGY CO.,LTDQUG2026-07-25
06980305290105CEARVOLSHENZHEN CANNICE TECHNOLOGY CO.,LTDQUG2026-07-25
06980305290112CEARVOLSHENZHEN CANNICE TECHNOLOGY CO.,LTDQUG2026-07-25
06980305290129CEARVOLSHENZHEN CANNICE TECHNOLOGY CO.,LTDQUG2026-07-25
06980134820016n/aBlue Deer Medical Equipment (guangdong) Co., Ltd.QUG2026-06-09
06980134820023n/aBlue Deer Medical Equipment (guangdong) Co., Ltd.QUG2026-06-09
06980134820030n/aBlue Deer Medical Equipment (guangdong) Co., Ltd.QUG2026-06-09
06980134820047n/aBlue Deer Medical Equipment (guangdong) Co., Ltd.QUG2026-06-09
06980134820054n/aBlue Deer Medical Equipment (guangdong) Co., Ltd.QUG2026-06-09
06980134820061n/aBlue Deer Medical Equipment (guangdong) Co., Ltd.QUG2026-06-09
06980134820078n/aBlue Deer Medical Equipment (guangdong) Co., Ltd.QUG2026-06-09
06980134820085n/aBlue Deer Medical Equipment (guangdong) Co., Ltd.QUG2026-06-09