FDA.reportPublic FDA data

NuvoMed

Primary DI
00810110301436
Brand
NuvoMed
Company
NUVOMED, INC.
Model
HNB-4/0143
Device description
DigiEars / LIGHT Bluetooth Neckband Hearing Aid
Published
2022-11-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

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
00810110301436PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810110301436008101103014368101103014360810110301436

GMDN Terms#

Term, Definition table
TermDefinition
Hearing aid neck induction loop, wireless inputA portable, battery-powered device worn around the neck intended to receive sound from an audio source [e.g., mobile (cellular) telephone] wirelessly (e.g., via Bluetooth) and transfer it via an audio frequency magnetic field to a hearing aid with an induction coil (i.e., bypassing the hearing aids microphone) when it is switched to the "T" or `?MT?? position, in order for the hearing aid user to hear (e.g., telephone conversation, music) more clearly. It typically consists of small active amplifier with a wire loop worn around the neck. It may also include a microphone for hands-free telephone conversation.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
080809709
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00859811007063NuvoMedBGTS50-24/07682018-09-04
00859811007681NuvoMed BGTS50-24/07682018-08-28
00859811009241NuvoMedTDT-6/09242020-10-30
00859811009234NuvoMedTBP-6/09232020-10-30
00859811009258NuvoMedTOS-6/09252020-10-30
00810110302099NuvoMedCTSS-12/02092024-03-22
00810110302105NuvoMedCTSL-12/02102024-03-22
00810110302112NuvoMedCTSX-12/02112024-03-22
00810110302129NuvoMedCTFP-6/02122024-03-22
00810110303492NuvoMedNWBP-6/03492024-10-18
00810110303508NuvoMedNABP-6/03502024-10-18
00810110303676NuvoMedLOS-12/03672024-12-13
00859811008947NuvoMedDCT-6/08942024-12-13
00859811007391NuvoMedFPO-6/07392018-09-10
00859811007261NuvoMedNGS50-24/07262019-01-29
00859811007414NuvomedMBG10-6/07412019-01-29
00810110302075NuvoMedBPMC-6/02072023-12-05
00859811007025NuvoMedNIET-6/07022018-06-15
00859811007018NuvoMedNBPM-6/07012018-06-15
00859811008510Bella RussoINV005642019-06-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06973967150658EaraXiamen Vienatone Medical Technology Co., Ltd.QUG2026-05-19
06971094538677AntOkayHuizhou Jinghao Medical Technology Co., LtdQUG2026-05-01
06973967150351Audien HearingXiamen Vienatone Medical Technology Co., Ltd.QUG2026-04-28
00860015094803LegatoLEGATO AUDIO, INC.QUG2026-03-25
00860015094810LegatoLEGATO AUDIO, INC.QUG2026-03-25
00860015094827LegatoLEGATO AUDIO, INC.QUG2026-03-25
00860015094834LegatoLEGATO AUDIO, INC.QUG2026-03-25
00850080488249flysoundShenzhen Flysounds Medical Technology Co.,Ltd.QUG2026-03-06
16974308960209Retone, NebrooXiamen Retone Hearing Technology Co., LtdQUG2026-02-05
00850080488140flysoundShenzhen Flysounds Medical Technology Co.,Ltd.QUG2026-01-16
05714880290325hear.comWs Audiology Usa, Inc.QUG2026-01-12
05714880290332hear.comWs Audiology Usa, Inc.QUG2026-01-12
05714880290349hear.comWs Audiology Usa, Inc.QUG2026-01-12
05714880290356hear.comWs Audiology Usa, Inc.QUG2026-01-12
16974308960193Retone Xiamen Retone Hearing Technology Co., LtdQUG2026-01-08
06977352080438ELEHEARELEHEAR Inc.QUG2025-12-31
06943786079911AUSTARAustar Hearing Science & Technology (Xiamen) Co., Ltd men) Co., Ltd.QUG2025-12-03
06975958551277MirasingXiamen Mirasing Technology Co.,Ltd.QUG2025-11-03
00810153660828Lexie H1 OTC Hearing BudsHEARX GROUP (PTY) LTDQUG2025-10-01
06971094538486H-earrings Huizhou Jinghao Medical Technology Co., LtdQUG2025-10-01
05708296386239GN HearingGn Hearing A/SQUG2025-09-21
05708296386246GN HearingGn Hearing A/SQUG2025-09-21
05708296391240GN HearingGn Hearing A/SQUG2025-09-21
05708296386253GN HearingGn Hearing A/SQUG2025-09-19
05708296386260GN HearingGn Hearing A/SQUG2025-09-19
05708296386277GN HearingGn Hearing A/SQUG2025-09-19
05708296386284GN HearingGn Hearing A/SQUG2025-09-19
05708296386291GN HearingGn Hearing A/SQUG2025-09-19
05708296386307GN HearingGn Hearing A/SQUG2025-09-19
05708296386314GN HearingGn Hearing A/SQUG2025-09-19