FDA.reportPublic FDA data

JVC

Primary DI
00046838505065
Brand
JVC
Company
Novidan, Inc.
Model
EH-Z2000-H
Device description
Self-Fit OTC Hearing Aid Pair, wireless, rechargeable, cool gray color
Published
2025-05-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
OTC
true

Product Codes#

Code, Name table
CodeName
QUHSelf-Fitting Air-Conduction Hearing Aid, Over The Counter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QUHSelf-Fitting Air-Conduction Hearing Aid, Over The CounterEar, Nose, Throat2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10046838505062PackageGS14In Commercial Distribution
00046838505065PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1004683850506210046838505062
00046838505065000468385050650468385050650046838505065

GMDN Terms#

Term, Definition table
TermDefinition
Air-conduction hearing aid, receiver-in-canalA battery-powered acoustic device intended to compensate for impaired hearing by transmitting amplified sound waves to the eardrum through air. It consists of a microphone and an amplifier in a case behind-the-ear (BTE) connected, via a wire, to a receiver (speaker) in the ear canal [receiver-in-canal (RIC)]. 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. 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
117003805
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850049194464Novidan99-0011-022024-11-25
00850049194471Novidan99-0011-012024-11-25
00850049194341NoviMed Hearing99-0017-012024-06-12
00850049194358NoviMed Hearing99-0017-022024-06-12
00850049194365NoviMed Hearing99-0017-032024-06-12
00850049194433NoviMed Hearing99-0017-042024-06-12
00850049194440NoviMed Hearing99-0017-052024-06-12
00850049194457NoviMed Hearing99-0017-062024-06-12
00850049194280Novidan99-0010-012024-05-15
00850049194297Novidan99-0010-022024-05-15
00850049194303Novidan99-0010-032024-05-15
00850049194310Sonify Hearing99-0016-012024-05-15
00850049194327Sonify Hearing99-0016-022024-05-15
00850049194334Sonify Hearing99-0016-032024-05-15
00850049194372Novidan99-0010-042024-05-15
00850049194389Novidan99-0010-052024-05-15
00850049194396Novidan99-0010-062024-05-15
00850049194402Sonify Hearing99-0016-042024-05-15
00850049194419Sonify Hearing99-0016-052024-05-15
00850049194426Sonify Hearing99-0016-062024-05-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05708296422043GN HearingGn Hearing A/SQUH2026-08-21
05708296422050GN HearingGn Hearing A/SQUH2026-08-21
05708296422067GN HearingGn Hearing A/SQUH2026-08-21
05708296422074GN HearingGn Hearing A/SQUH2026-08-21
05708296422081GN HearingGn Hearing A/SQUH2026-08-21
05708296422098GN HearingGn Hearing A/SQUH2026-08-21
05708296422104GN HearingGn Hearing A/SQUH2026-08-21
05708296422111GN HearingGn Hearing A/SQUH2026-08-21
05708296422128GN HearingGn Hearing A/SQUH2026-08-21
05708296422135GN HearingGn Hearing A/SQUH2026-08-21
05708296422142GN HearingGn Hearing A/SQUH2026-08-21
05708296422159GN HearingGn Hearing A/SQUH2026-08-21
05708296422166GN HearingGn Hearing A/SQUH2026-08-21
05708296422173GN HearingGn Hearing A/SQUH2026-08-21
05708296422180GN HearingGn Hearing A/SQUH2026-08-21
05708296422197GN HearingGn Hearing A/SQUH2026-08-21
05708296422203GN HearingGn Hearing A/SQUH2026-08-21
05708296422210GN HearingGn Hearing A/SQUH2026-08-21
05708296422227GN HearingGn Hearing A/SQUH2026-08-21
05708296422234GN HearingGn Hearing A/SQUH2026-08-21
05708296422241GN HearingGn Hearing A/SQUH2026-08-21
05708296422258GN HearingGn Hearing A/SQUH2026-08-21
05708296422265GN HearingGn Hearing A/SQUH2026-08-21
05708296422272GN HearingGn Hearing A/SQUH2026-08-21
05708296422289GN HearingGn Hearing A/SQUH2026-08-21
05708296422296GN HearingGn Hearing A/SQUH2026-08-21
05708296422302GN HearingGn Hearing A/SQUH2026-08-21
05708296422319GN HearingGn Hearing A/SQUH2026-08-21
05708296422326GN HearingGn Hearing A/SQUH2026-08-21
05708296422333GN HearingGn Hearing A/SQUH2026-08-21