FDA.reportPublic FDA data

Melosound

Primary DI
06972665720286
Brand
Melosound
Company
Xiamen Melosound Technology CO.,Ltd
Model
Faceplate
Published
2023-01-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
LRBFace Plate Hearing Aid

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LRBFace Plate Hearing AidEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06972665720286PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06972665720286069726657202866972665720286

GMDN Terms#

Term, Definition table
TermDefinition
Air-conduction hearing aid, in-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 miniature microphone, amplifier, and speaker (receiver) contained in a case that fits completely inside the outer ear (concha) [in-the-ear (ITE)]. 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 severe hearing loss; most types are programmable to enable computerized adjustments for a patient's hearing loss and related factors.

Regulatory Flags#

DUNS number
551745815
Device count
1
Premarket exempt
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06972665720958melosoundSonix 1072026-05-08
06972665720002MelosoundCIC2024-05-09
06972665720293MelosoundARIC P2024-05-09
06972665720392MelosoundCIC-P2024-05-09
06972665720538MelosoundBTE P 2024-05-09
06972665720606MelosoundITC-P2024-05-09
06972665720620MelosoundBTE UP2024-05-09
06972665720637MelosoundBTE SP2024-05-09
06972665720552MelosoundITE2024-05-08
06972665720576MelosoundITC2024-05-08
06972665720446MelosoundPeri P11S2024-01-09
06972665720415MelosoundPopo RP40M2023-11-09
06972665720156MelosoundMuse 1600M RIC2023-01-04
06972665720194MelosoundModo RM1200M B2023-01-04
06972665720200MelosoundModo RM1200M BA2023-01-04
06972665720224MelosoundModo RM1600M BA2023-01-05
06972665720170MelosoundModo RM40M2023-01-04
06972665720187MelosoundModo RM60M2023-01-04
06972665720262MelosoundPingu 80 B2023-01-05
06972665720217MelosoundModo RM1600M B2023-01-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05714464167012BirdsongSbo Hearing A/SLRB2026-03-26
05714464167029BirdsongSbo Hearing A/SLRB2026-03-26
05714464167036BirdsongSbo Hearing A/SLRB2026-03-26
05714464167043BirdsongSbo Hearing A/SLRB2026-03-26
05714464167050BirdsongSbo Hearing A/SLRB2026-03-26
05714464167067BirdsongSbo Hearing A/SLRB2026-03-26
05714464167074BirdsongSbo Hearing A/SLRB2026-03-26
05714464167081BirdsongSbo Hearing A/SLRB2026-03-26
05714464167098BirdsongSbo Hearing A/SLRB2026-03-26
05714464167104BirdsongSbo Hearing A/SLRB2026-03-26
05714464167111BirdsongSbo Hearing A/SLRB2026-03-26
05714464167128BirdsongSbo Hearing A/SLRB2026-03-26
05714464167135BirdsongSbo Hearing A/SLRB2026-03-26
05714464167142BirdsongSbo Hearing A/SLRB2026-03-26
05714464167159BirdsongSbo Hearing A/SLRB2026-03-26
05714464148103PhilipsSbo Hearing A/SLRB2025-02-10
05714464148110PhilipsSbo Hearing A/SLRB2025-02-10
05714464148202OticonSbo Hearing A/SLRB2025-02-10
05714464148219OticonSbo Hearing A/SLRB2025-02-10
05714464148226OticonSbo Hearing A/SLRB2025-02-10
05714464148233OticonSbo Hearing A/SLRB2025-02-10
05714464148240OticonSbo Hearing A/SLRB2025-02-10
05714464148257OticonSbo Hearing A/SLRB2025-02-10
05714464148264OticonSbo Hearing A/SLRB2025-02-10
05714464148271OticonSbo Hearing A/SLRB2025-02-10
05714464148288BernafonSbo Hearing A/SLRB2025-02-10
05714464148295BernafonSbo Hearing A/SLRB2025-02-10
05714464148301BernafonSbo Hearing A/SLRB2025-02-10
05714464148318BernafonSbo Hearing A/SLRB2025-02-10
05714464148325BernafonSbo Hearing A/SLRB2025-02-10