FDA.report

TIANLE

Primary DI
06937572802005
Brand
TIANLE
Company
Zhongshan Tianle Hearing Technology Co., Ltd.
Model
TL-218F
Device description
In The Canal Hearing Aid
Published
2025-03-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
QUFHearing Aid, Air-Conduction, Over The Counter

Product Code Classifications

CodeDeviceSpecialtyClass
QUFHearing Aid, Air-Conduction, Over The CounterEar, Nose, Throat1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
06937572802005PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
06937572802005069375728020056937572802005

GMDN Terms

TermDefinition
Air-conduction hearing aid, canalA 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) in a case that fits the ear canal [in-the-canal (ITC)] or in a case nearly hidden in the ear canal [completely-in-the-canal (CIC)]. 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. It is used for mild to moderately-severe hearing loss; most types are programmable to enable computerized adjustments for a patient's hearing loss and related factors.

Sterilization Methods

Method

Regulatory Flags

DUNS number
546790267
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 DIBrandModelCatalogPublished
06937572802470TIANLETF-950F2025-04-02
06937572802487TIANLETF-951F2025-04-02
06937572803750TIANLETL-621G2025-04-02
06937572803767TIANLETL-622G2025-04-02
06937572803774TIANLETL-623G2025-04-02
06937572803781TIANLETL-625G2025-04-02
06937572803798TIANLETL-626G2025-04-02
06937572803804TIANLETL-628G2025-04-02
06937572803811TIANLETL-629G2025-04-02
06937572803828TIANLETL-630G2025-04-02
06937572803835TIANLETL-631G2025-04-02
06937572803842TIANLETL-632G2025-04-02
06937572803859TIANLETL-633G2025-04-02
06937572803866TIANLETL-635G2025-04-02
06937572803873TIANLETL-636G2025-04-02
06937572803880TIANLETL-638G2025-04-02
06937572803897TIANLETL-639G2025-04-02
06937572803903TIANLETL-650G2025-04-02
06937572803910TIANLETL-651G2025-04-02
06937572803927TIANLETL-652G2025-04-02

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
06971094538639Spade & CoHuizhou Jinghao Medical Technology Co., LtdQUF2026-03-24
06971094538615GIATATHAHuizhou Jinghao Medical Technology Co., LtdQUF2026-03-20
06971094538585Bachgold Huizhou Jinghao Medical Technology Co., LtdQUF2026-02-05
06979053570034UltrotingShenzhen Magnet Technology Co., LtdQUF2026-01-21
06979053570041UltrotingShenzhen Magnet Technology Co., LtdQUF2026-01-21
06971094538530LITOULFHuizhou Jinghao Medical Technology Co., LtdQUF2025-12-19
06978898058011Viva HearShenzhen Cresendo Technology Co.,Ltd.QUF2025-12-12
06978898058028Viva HearShenzhen Cresendo Technology Co.,Ltd.QUF2025-12-12
06978898058035Viva HearShenzhen Cresendo Technology Co.,Ltd.QUF2025-12-12
06978898058042Xpect VisionShenzhen Cresendo Technology Co.,Ltd.QUF2025-12-12
06978898058059Xpect VisionShenzhen Cresendo Technology Co.,Ltd.QUF2025-12-12
06978898058066Xpect VisionShenzhen Cresendo Technology Co.,Ltd.QUF2025-12-12
06975958550010MirasingXiamen Mirasing Technology Co.,Ltd.QUF2025-12-09
06975958550119MirasingXiamen Mirasing Technology Co.,Ltd.QUF2025-12-09
06975958550225MirasingXiamen Mirasing Technology Co.,Ltd.QUF2025-12-09
06975958550232MirasingXiamen Mirasing Technology Co.,Ltd.QUF2025-12-09
06975958550249MirasingXiamen Mirasing Technology Co.,Ltd.QUF2025-12-09
06975958550256MirasingXiamen Mirasing Technology Co.,Ltd.QUF2025-12-09
06975958550263MirasingXiamen Mirasing Technology Co.,Ltd.QUF2025-12-09
06975958550270MirasingXiamen Mirasing Technology Co.,Ltd.QUF2025-12-09
06975958550287MirasingXiamen Mirasing Technology Co.,Ltd.QUF2025-12-09
06975958550294MirasingXiamen Mirasing Technology Co.,Ltd.QUF2025-12-09
06975958550300MirasingXiamen Mirasing Technology Co.,Ltd.QUF2025-12-09
06975958550324MirasingXiamen Mirasing Technology Co.,Ltd.QUF2025-12-09
06975958550331MirasingXiamen Mirasing Technology Co.,Ltd.QUF2025-12-09
06975958550362MirasingXiamen Mirasing Technology Co.,Ltd.QUF2025-12-09
06975958550379MirasingXiamen Mirasing Technology Co.,Ltd.QUF2025-12-09
06975958550386MirasingXiamen Mirasing Technology Co.,Ltd.QUF2025-12-09
06975958550676MirasingXiamen Mirasing Technology Co.,Ltd.QUF2025-12-09
06971094539483JINGHAOHuizhou Jinghao Medical Technology Co., LtdQUF2025-12-08