FDA.reportPublic FDA data

Lucid®

Primary DI
00810068831788
Brand
Lucid®
Company
HEARING LAB TECHNOLOGY, LLC
Model
7495
Catalog number
10080-L REPLACE
Device description
Engage Android Rechargeable OTC Beige Replacement Left
Published
2023-07-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
QUGHearing Aid, Air-Conduction with Wireless Technology, Over the Counter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QUGHearing Aid, Air-Conduction With Wireless Technology, Over The CounterEar, Nose, Throat2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810068831788PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810068831788008100688317888100688317880810068831788

GMDN Terms#

Term, Definition table
TermDefinition
Air-conduction hearing aid, receiver-in-the-earA 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 or microphones and an amplifier in a case behind-the-ear (BTE) connected, via a wire, to a receiver (speaker) in the outer ear [receiver-in-the-ear (RITE)]. The microphone(s) 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

Contacts#

Phone, Email table
PhoneEmail
+1(800)785-6052support@lucidhearing.com

Regulatory Flags#

DUNS number
827693503
Device count
1
Premarket exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810068833119Lucid Hearing®756*LH-Lucid One2026-02-13
00810068833126Lucid Hearing®746*LH-Lucid One-A2026-02-13
00810068833133Lucid Hearing®316*LH-Lucid II2026-02-13
00810068833140Lucid Hearing®306*LH-Lucid II-A2026-02-13
00810068833157Lucid Hearing®616*0LH-Lucid III2026-02-13
00810068833164Lucid Hearing®606*0LH-Lucid III-A2026-02-13
00810068833171Lucid Hearing®306*LH-A64BT-BG-PKG2026-02-13
00810068833188Lucid Hearing®316*LH-U64BT-BG-PKG2026-02-13
00810068833195Lucid Hearing®146*HLT-A32WL-BG-PKG2026-02-13
00810068833201Lucid Hearing®156*HLT-U32WL-BG-PKG2026-02-13
00810068833218Lucid Hearing®906*HLT-SIE16-BG2PK-PKG2026-02-13
00810068832136Lucid Hearing®106*LH-A32BT-BG2025-09-26
00810068832143Lucid Hearing®116*LH-U32BT-BG2025-09-26
00810068832150Lucid Hearing®106*LH-A32BT-GR2025-09-26
00810068832167Lucid Hearing®116*LH-U32BT-GR2025-09-26
00810068832174Lucid Hearing®106*LH-A32BT-BK2025-09-26
00810068832181Lucid Hearing®116*LH-U32BT-BK2025-09-26
00810068832198Lucid Hearing®106*LH-A32BT-BR2025-09-26
00810068832204Lucid Hearing®116*LH-U32BT-BR2025-09-26
00810068832211Lucid Hearing®506*LH-A128BT-PSL2025-09-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06973967150658EaraXiamen Vienatone Medical Technology Co., Ltd.QUG2026-05-19
06971094538677AntOkayHuizhou Jinghao Medical Technology Co., LtdQUG2026-05-01
06973967150351Audien HearingXiamen Vienatone Medical Technology Co., Ltd.QUG2026-04-28
00860015094803LegatoLEGATO AUDIO, INC.QUG2026-03-25
00860015094810LegatoLEGATO AUDIO, INC.QUG2026-03-25
00860015094827LegatoLEGATO AUDIO, INC.QUG2026-03-25
00860015094834LegatoLEGATO AUDIO, INC.QUG2026-03-25
00850080488249flysoundShenzhen Flysounds Medical Technology Co.,Ltd.QUG2026-03-06
16974308960209Retone, NebrooXiamen Retone Hearing Technology Co., LtdQUG2026-02-05
00850080488140flysoundShenzhen Flysounds Medical Technology Co.,Ltd.QUG2026-01-16
05714880290325hear.comWs Audiology Usa, Inc.QUG2026-01-12
05714880290332hear.comWs Audiology Usa, Inc.QUG2026-01-12
05714880290349hear.comWs Audiology Usa, Inc.QUG2026-01-12
05714880290356hear.comWs Audiology Usa, Inc.QUG2026-01-12
16974308960193Retone Xiamen Retone Hearing Technology Co., LtdQUG2026-01-08
06977352080438ELEHEARELEHEAR Inc.QUG2025-12-31
06943786079911AUSTARAustar Hearing Science & Technology (Xiamen) Co., Ltd men) Co., Ltd.QUG2025-12-03
06975958551277MirasingXiamen Mirasing Technology Co.,Ltd.QUG2025-11-03
00810153660828Lexie H1 OTC Hearing BudsHEARX GROUP (PTY) LTDQUG2025-10-01
06971094538486H-earrings Huizhou Jinghao Medical Technology Co., LtdQUG2025-10-01
05708296386239GN HearingGn Hearing A/SQUG2025-09-21
05708296386246GN HearingGn Hearing A/SQUG2025-09-21
05708296391240GN HearingGn Hearing A/SQUG2025-09-21
05708296386253GN HearingGn Hearing A/SQUG2025-09-19
05708296386260GN HearingGn Hearing A/SQUG2025-09-19
05708296386277GN HearingGn Hearing A/SQUG2025-09-19
05708296386284GN HearingGn Hearing A/SQUG2025-09-19
05708296386291GN HearingGn Hearing A/SQUG2025-09-19
05708296386307GN HearingGn Hearing A/SQUG2025-09-19
05708296386314GN HearingGn Hearing A/SQUG2025-09-19