FDA.reportPublic FDA data

Lucid Hearing®

Primary DI
00810068832228
Brand
Lucid Hearing®
Company
HEARING LAB TECHNOLOGY, LLC
Model
516*
Catalog number
LH-U128BT-PSL
Device description
U128BT Silver Hearing Aid
Published
2025-09-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Contact Domains#

Product Codes#

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

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810068832228PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810068832228008100688322288100688322280810068832228

GMDN Terms#

Term, Definition table
TermDefinition
Air-conduction hearing aid, receiver-in-canalA 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 and an amplifier in a case behind-the-ear (BTE) connected, via a wire, to a receiver (speaker) in the ear canal [receiver-in-canal (RIC)]. 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 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)492-4515support@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
07613389927696Phonak CROS E-RSonova AGOSM2026-08-03
07613389927719Phonak CROS E-RSonova AGOSM2026-08-03
07613389927726Phonak CROS E-RSonova AGOSM2026-08-03
07613389927733Phonak CROS E-RSonova AGOSM2026-08-03
07613389927740Phonak CROS E-RSonova AGOSM2026-08-03
07613389927757Phonak CROS E-RSonova AGOSM2026-08-03
07613389927764Phonak CROS E-RSonova AGOSM2026-08-03
07613389927771Phonak CROS E-RSonova AGOSM2026-08-03
07613389928181Phonak CROS E-RSonova AGOSM2026-08-03
05714878800291MIRACLE EARWs Audiology Usa, Inc.OSM2026-07-29
05714878800307MIRACLE EARWs Audiology Usa, Inc.OSM2026-07-29
05714878800314MIRACLE EARWs Audiology Usa, Inc.OSM2026-07-29
05714878800352MIRACLE EARWs Audiology Usa, Inc.OSM2026-07-29
07613389840599Moxi S9-RXSonova AGOSM2026-07-26
07613389840605Moxi S9-RXSonova AGOSM2026-07-26
07613389842012Moxi S7-RXSonova AGOSM2026-07-26
07613389842029Moxi S7-RXSonova AGOSM2026-07-26
07613389842036Moxi S7-RXSonova AGOSM2026-07-26
07613389842043Moxi S7-RXSonova AGOSM2026-07-26
07613389842050Moxi S7-RXSonova AGOSM2026-07-26
07613389842067Moxi S7-RXSonova AGOSM2026-07-26
07613389842074Moxi S9-RXSonova AGOSM2026-07-26
07613389842081Moxi S9-RXSonova AGOSM2026-07-26
07613389842098Moxi S9-RXSonova AGOSM2026-07-26
07613389842104Moxi S9-RXSonova AGOSM2026-07-26
07613389842111Moxi S-RX FLEX:TRIALSonova AGOSM2026-07-26
07613389843682Relate5.0 Platinum RIC RXSonova AGOSM2026-07-26
07613389843699Relate5.0 RIC RX DEMOSonova AGOSM2026-07-26
07613389844627Relate5.0 Gold RIC RXSonova AGOSM2026-07-26
07613389844634Relate5.0 Gold RIC RXSonova AGOSM2026-07-26