FDA.reportPublic FDA data

Lucid Audio

Primary DI
00846430006003
Brand
Lucid Audio
Company
ETYMOTIC RESEARCH, INC.
Model
Accent 20218
Device description
Accent Bluetooth rechargeable 1401 - Android WH - 32 channel *Sam's Club20218
Published
2024-08-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
00846430006003PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00846430006003008464300060038464300060030846430006003

GMDN Terms#

Term, Definition table
TermDefinition
Air-conduction hearing aid, in-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 miniature microphone, amplifier, and speaker (receiver) contained in a case that fits completely inside the outer ear (concha) [in-the-ear (ITE)]. 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 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
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
05714880296440SIGNIAWs Audiology Usa, Inc.OSM2026-07-22
05714880296464SIGNIAWs Audiology Usa, Inc.OSM2026-07-22
05714880296488SIGNIAWs Audiology Usa, Inc.OSM2026-07-22
05714880296501SIGNIAWs Audiology Usa, Inc.OSM2026-07-22
05714880296525SIGNIAWs Audiology Usa, Inc.OSM2026-07-22
05714880296549SIGNIAWs Audiology Usa, Inc.OSM2026-07-22
05714880296563SIGNIAWs Audiology Usa, Inc.OSM2026-07-22
05714880296587SIGNIAWs Audiology Usa, Inc.OSM2026-07-22
05714880296600SIGNIAWs Audiology Usa, Inc.OSM2026-07-22
05714880296624SIGNIAWs Audiology Usa, Inc.OSM2026-07-22
05714880296648SIGNIAWs Audiology Usa, Inc.OSM2026-07-22
05714880296679SIGNIAWs Audiology Usa, Inc.OSM2026-07-22
05714880296709SIGNIAWs Audiology Usa, Inc.OSM2026-07-22
05714880296716SIGNIAWs Audiology Usa, Inc.OSM2026-07-22
05714880296747SIGNIAWs Audiology Usa, Inc.OSM2026-07-22
05714880296754SIGNIAWs Audiology Usa, Inc.OSM2026-07-22
05714880296853SIGNIAWs Audiology Usa, Inc.OSM2026-07-22
05714880296860SIGNIAWs Audiology Usa, Inc.OSM2026-07-22
05714880296877SIGNIAWs Audiology Usa, Inc.OSM2026-07-22
05714880296884SIGNIAWs Audiology Usa, Inc.OSM2026-07-22
05714880296891SIGNIAWs Audiology Usa, Inc.OSM2026-07-22
05714880296907SIGNIAWs Audiology Usa, Inc.OSM2026-07-22
05714880296914SIGNIAWs Audiology Usa, Inc.OSM2026-07-22
05714880297010SIGNIAWs Audiology Usa, Inc.OSM2026-07-22
05714880297027SIGNIAWs Audiology Usa, Inc.OSM2026-07-22
05714880297034SIGNIAWs Audiology Usa, Inc.OSM2026-07-22
05714880297041SIGNIAWs Audiology Usa, Inc.OSM2026-07-22
05714880297058SIGNIAWs Audiology Usa, Inc.OSM2026-07-22
05714880297065SIGNIAWs Audiology Usa, Inc.OSM2026-07-22
05714880297072SIGNIAWs Audiology Usa, Inc.OSM2026-07-22