FDA.reportPublic FDA data

Aspire

Primary DI
00812944028060
Brand
Aspire
Company
HEARING LAB TECHNOLOGY, LLC
Model
4560
Catalog number
HLT-U96WL-GR
Device description
Universal 96ch WL Gray
Published
2020-02-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
OSMHearing aid, air conduction with wireless technology

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
00812944028060PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00812944028060008129440280608129440280600812944028060

GMDN Terms#

Term, Definition table
TermDefinition
Receiver-in-the-ear air-conduction hearing aidA 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)785-6052help@aspirehearingaids.com

Regulatory Flags#

DUNS number
827693503
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
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 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
05714880292077WidexWidex A/SOSM2026-05-22
05714880292084WidexWidex A/SOSM2026-05-22
05714880292091WidexWidex A/SOSM2026-05-22
05714880292107WidexWidex A/SOSM2026-05-22
05714880292114WidexWidex A/SOSM2026-05-22
05714880292121WidexWidex A/SOSM2026-05-22
05714880292138WidexWidex A/SOSM2026-05-22
05714880292145WidexWidex A/SOSM2026-05-22
05714880292152WidexWidex A/SOSM2026-05-22
05714880292169WidexWidex A/SOSM2026-05-22
05714880292176WidexWidex A/SOSM2026-05-22
05714880292183WidexWidex A/SOSM2026-05-22
05714880292190WidexWidex A/SOSM2026-05-22
05714880292206WidexWidex A/SOSM2026-05-22
05714880292213WidexWidex A/SOSM2026-05-22
05714880292220WidexWidex A/SOSM2026-05-22
05714880292237WidexWidex A/SOSM2026-05-22
05714880292244WidexWidex A/SOSM2026-05-22
05714880292251WidexWidex A/SOSM2026-05-22
05714880292268WidexWidex A/SOSM2026-05-22
05714880292275WidexWidex A/SOSM2026-05-22
05714880292282WidexWidex A/SOSM2026-05-22
05714880292299WidexWidex A/SOSM2026-05-22
05714880292305WidexWidex A/SOSM2026-05-22
05714880292312WidexWidex A/SOSM2026-05-22
05714880292329WidexWidex A/SOSM2026-05-22
05714880292336WidexWidex A/SOSM2026-05-22
05714880292343WidexWidex A/SOSM2026-05-22
05714880292350WidexWidex A/SOSM2026-05-22
05714880292367WidexWidex A/SOSM2026-05-22