FDA.reportPublic FDA data

Lucid Audio

Primary DI
00846430005587
Brand
Lucid Audio
Company
ETYMOTIC RESEARCH, INC.
Model
Enlite clear
Device description
Hearing aid, clear, non-rechargeable
Published
2022-11-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
QUFHearing Aid, Air-Conduction, Over The Counter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QUFHearing Aid, Air-Conduction, Over The CounterEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00846430005587PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00846430005587008464300055878464300055870846430005587

GMDN Terms#

Term, Definition table
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 table
Method

Contacts#

Phone, Email table
PhoneEmail
866-202-2527support@lucidhearing.com
1-866-202-2527support@lucidhearing.com

Regulatory Flags#

DUNS number
115380859
Device count
1
Premarket exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00846430004443N/AER3-14B2016-09-19
00846430005426Etymotic ResearchER3-19-S12023-04-04
00846430005600EtymoticER3-14B-5002023-04-04
00846430005617EtymoticER3-14C-5002023-04-04
00846430005457EtymoticER3-192022-11-14
00846430005563EtymoticER13-14C2022-11-10
00846430005440N/AER3C-300 System2022-02-07
00846430005488N/AER3C-3002022-02-04
00846430005334Etymotic ResearchER3C-842022-01-26
00846430004078Single Use EartipER10D-T032016-09-20
00846430004085Single Use EartipER10D-T042016-09-19
00846430004092Single Use EartipER10D-T052016-09-20
00846430004108Single Use EartipER10-T062016-09-19
00846430004115Single Use EartipER10D-T072016-09-20
00846430004122Single Use EartipER10D-T082016-09-20
00846430004139Single Use EartipER10D-T092016-09-19
00846430004146Single Use EartipsER10D-T102016-09-19
00846430004153Single Use EartipER10D-T112016-09-20
00846430004160Single Use EartipER10D-T122016-09-20
00846430004177Single Use EartipER10D-T132016-09-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06971094538790SOUNDFITHuizhou Jinghao Medical Technology Co., LtdQUF2026-07-03
00850065321714CeretoneAudicon CorporationQUF2026-06-25
00850065321752CeretoneAudicon CorporationQUF2026-06-25
06971094538783Smart HearingHuizhou Jinghao Medical Technology Co., LtdQUF2026-06-22
06977171530046TECHMITechmi (HongKong) Co., LimitedQUF2026-06-10
06977171530008TECHMITechmi (HongKong) Co., LimitedQUF2026-06-03
06977171530015TECHMITechmi (HongKong) Co., LimitedQUF2026-06-03
06977171530022TECHMITechmi (HongKong) Co., LimitedQUF2026-06-03
06977171530039TECHMITechmi (HongKong) Co., LimitedQUF2026-06-03
06971094538721KLARIQHuizhou Jinghao Medical Technology Co., LtdQUF2026-05-26
06971094538738KLARIQHuizhou Jinghao Medical Technology Co., LtdQUF2026-05-26
06971094538707XQYMHuizhou Jinghao Medical Technology Co., LtdQUF2026-05-08
06971094538691OricleHuizhou Jinghao Medical Technology Co., LtdQUF2026-04-30
06973967150276WuveeXiamen Vienatone Medical Technology Co., Ltd.QUF2026-04-28
06973967150283NebrooXiamen Vienatone Medical Technology Co., Ltd.QUF2026-04-28
06973967150313VienatoneXiamen Vienatone Medical Technology Co., Ltd.QUF2026-04-28
06973967150320VienatoneXiamen Vienatone Medical Technology Co., Ltd.QUF2026-04-28
06973967150368NebrooXiamen Vienatone Medical Technology Co., Ltd.QUF2026-04-28
06973967150573VienatoneXiamen Vienatone Medical Technology Co., Ltd.QUF2026-04-28
06971094538622Savvy SmartHuizhou Jinghao Medical Technology Co., LtdQUF2026-03-25
06971094538639Spade & CoHuizhou Jinghao Medical Technology Co., LtdQUF2026-03-24
06971094538615GIATATHAHuizhou Jinghao Medical Technology Co., LtdQUF2026-03-20
06971094538592LITOULFHuizhou Jinghao Medical Technology Co., LtdQUF2026-03-18
06950715563090CofoeCofoe Medical Technology Co.,LtdQUF2026-02-24
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