FDA.reportPublic FDA data

ACOSOUND

Primary DI
06973375880154
Brand
ACOSOUND
Company
Hangzhou AcoSound Technology Co.,Ltd.
Model
Leya-W-BTE-P
Published
2022-04-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
ESDHearing Aid, Air Conduction
OSMHearing Aid, Air-Conduction With Wireless Technology, Prescription

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ESDHearing Aid, Air-Conduction, PrescriptionEar, Nose, Throat1
OSMHearing Aid, Air-Conduction With Wireless Technology, PrescriptionEar, Nose, Throat2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06973375880154PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06973375880154069733758801546973375880154

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
542986440
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06973375883322AcoSoundTW-IF-P L2025-08-14
06973375883339AcoSoundTW-IF-P R2025-08-14
06973375883346AcoSoundTW-IF-C L2025-08-14
06973375883353AcoSoundTW-IF-C R2025-08-14
06973375883193AcoSoundLeya-ITC2025-07-09
06973375883117AcoSoundLeya-W- BTE-M(1 pair)2025-06-18
06973375883124AcoSoundLeya-W- BTE-M2025-06-18
06973375883131AcoSoundTW-RIC-C(left)2025-06-18
06973375883148AcoSoundTW-RIC-C(right)2025-06-18
06973375883025AcoSoundTW-IF-C2024-12-30
06973375880710AcoSoundSonarPro2023-06-07
06973375880765AcoSoundTW-IF-P2023-06-07
06973375880727AcoSoundTW-RIC-M2023-04-19
06973375880734AcoSoundTW-RIC-C2023-04-19
06973375880406AcoSoundLeya-IF2022-11-14
06973375880413AcoSoundLeya-IF-N2022-11-14
06973375880420AcoSoundLeya-IF-P2022-11-14
06973375880437AcoSoundLeya-IF-P-N2022-11-14
06973375880444AcoSoundLeya-RIC-S2022-11-14
06973375880451AcoSoundLeya-RIC-S-N2022-11-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05708296394029BeltoneGn Hearing A/SOSM2026-10-05
05708296394036BeltoneGn Hearing A/SOSM2026-10-05
05708296394098BeltoneGn Hearing A/SOSM2026-10-05
05708296394104BeltoneGn Hearing A/SOSM2026-10-05
05708296394111BeltoneGn Hearing A/SOSM2026-10-05
05708296394128BeltoneGn Hearing A/SOSM2026-10-05
05708296394135BeltoneGn Hearing A/SOSM2026-10-05
05708296394197BeltoneGn Hearing A/SOSM2026-10-05
05708296394203BeltoneGn Hearing A/SOSM2026-10-05
05708296394210BeltoneGn Hearing A/SOSM2026-10-05
05708296394487BeltoneGn Hearing A/SOSM2026-10-05
05708296394494BeltoneGn Hearing A/SOSM2026-10-05
05708296394555BeltoneGn Hearing A/SOSM2026-10-05
05708296394562BeltoneGn Hearing A/SOSM2026-10-05
05708296394579BeltoneGn Hearing A/SOSM2026-10-05
05708296394586BeltoneGn Hearing A/SOSM2026-10-05
05708296394593BeltoneGn Hearing A/SOSM2026-10-05
05708296394654BeltoneGn Hearing A/SOSM2026-10-05
05708296394661BeltoneGn Hearing A/SOSM2026-10-05
05708296394678BeltoneGn Hearing A/SOSM2026-10-05
05708296397877BeltoneGn Hearing A/SOSM2026-10-05
05708296397884BeltoneGn Hearing A/SOSM2026-10-05
05708296397945BeltoneGn Hearing A/SOSM2026-10-05
05708296397952BeltoneGn Hearing A/SOSM2026-10-05
05708296397969BeltoneGn Hearing A/SOSM2026-10-05
05708296429455BeltoneGn Hearing A/SOSM2026-10-05
05708296429462BeltoneGn Hearing A/SOSM2026-10-05
05708296429523BeltoneGn Hearing A/SOSM2026-10-05
05708296429530BeltoneGn Hearing A/SOSM2026-10-05
05708296429547BeltoneGn Hearing A/SOSM2026-10-05