FDA.reportPublic FDA data

Audioprosthesis

Primary DI
08056138805507
Brand
Audioprosthesis
Company
AUDIO TECHNOLOGIES SRL
Model
TPL 07.75
Catalog number
TPL 07.75
Device description
Ti FOOTPLATE OTOSURGERY PROSTHESIS
Published
2026-10-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
ETBPROSTHESIS, PARTIAL OSSICULAR REPLACEMENT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ETBProsthesis, Partial Ossicular ReplacementEar, Nose, Throat2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K001142000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K001142000AUDIO TECHNOLOGIES S:R.1Audio Technologies S.R.L.2000-06-23ETB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08056138805507PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08056138805507080561388055078056138805507

GMDN Terms#

Term, Definition table
TermDefinition
Ossicular prosthesis, partialA sterile device intended to be implanted for the functional reconstruction of segments of the ossicular chain (mallues, incus, and/or stapes bones) to facilitate the conduction of sound waves from the tympanic membrane to the inner ear. It is designed to treat conductive hearing loss from traumatic or surgical injury, otosclerosis, congenital fixation of the stapes, or chronic middle ear disease. The device is typically in the form of a tube made of metal [e.g., stainless steel, titanium (Ti)], polymers, or a combination of these materials.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length0
Outer Diameter0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature00

Contacts#

Phone, Email table
PhoneEmail
+390523778864info@audiotechnologies.it

Regulatory Flags#

DUNS number
459394425
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
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
08056138800021AudioprosthesisSPL 03.00.400SPL 03.00.4002026-10-22
08056138800137AudioprosthesisSPL 03.04.475SPL 03.04.4752026-10-22
08056138805453AudioprosthesisTPL 07.51TPL 07.512026-10-22
08056138805484AudioprosthesisTPL 07.73TPL 07.732026-10-22
08056138805491AudioprosthesisTPL 07.74TPL 07.742026-10-22
08056138805514AudioprosthesisTPL 07.76TPL 07.762026-10-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08056138800021AudioprosthesisAUDIO TECHNOLOGIES SRLETB2026-10-22
08056138800137AudioprosthesisAUDIO TECHNOLOGIES SRLETB2026-10-22
08056138805453AudioprosthesisAUDIO TECHNOLOGIES SRLETB2026-10-22
08056138805484AudioprosthesisAUDIO TECHNOLOGIES SRLETB2026-10-22
08056138805491AudioprosthesisAUDIO TECHNOLOGIES SRLETB2026-10-22
08056138805514AudioprosthesisAUDIO TECHNOLOGIES SRLETB2026-10-22
00844505010269TITANIUM/FLUOROPLASTIC PISTONGrace Medical, Inc.ETB2026-02-03
00844505014526GRACE PISTONGrace Medical, Inc.ETB2026-01-07
00844505014533GRACE PISTONGrace Medical, Inc.ETB2026-01-07
00844505014540GRACE PISTONGrace Medical, Inc.ETB2026-01-07
00844505014502TITANIUM PISTONGrace Medical, Inc.ETB2025-09-18
00844505014687GRACE MEDICAL FLUOROPLASTIC PISTONGrace Medical, Inc.ETB2025-09-18
00844505014489ECLIPSE PISTONGrace Medical, Inc.ETB2025-08-05
00844505014519TITANIUM PISTONGrace Medical, Inc.ETB2025-08-05
00844505014564GRACE MEDICAL FLUOROPLASTIC PISTONGrace Medical, Inc.ETB2025-08-05
00844505014670GRACE MEDICAL FLUOROPLASTIC PISTONGrace Medical, Inc.ETB2025-08-05
00844505014649NYTEBYTEGrace Medical, Inc.ETB2025-07-02
00763000913731N/AMEDTRONIC XOMED, INC.ETB2025-06-23
00821925035478Gyrus ACMIGyrus ACMI, LLCETB2024-07-25
00763000036591Big Easy® PistonMEDTRONIC XOMED, INC.ETB2024-05-12
00763000036607Big Easy® PistonMEDTRONIC XOMED, INC.ETB2024-05-12
00763000036614Big Easy® PistonMEDTRONIC XOMED, INC.ETB2024-05-12
00763000036621Big Easy® PistonMEDTRONIC XOMED, INC.ETB2024-05-12
00763000036638Big Easy® PistonMEDTRONIC XOMED, INC.ETB2024-05-12
00763000036645Big Easy® PistonMEDTRONIC XOMED, INC.ETB2024-05-12
EHKM10022601CliP Partial Prosthesis TitaniumHeinz Kurz GmbHETB2023-09-29
EHKM10022641CliP Partial Prosthesis TitaniumHeinz Kurz GmbHETB2023-09-29
EHKM10022661CliP Partial Prosthesis TitaniumHeinz Kurz GmbHETB2023-09-29
EHKM10022681CliP Partial Prosthesis TitaniumHeinz Kurz GmbHETB2023-09-29
EHKM10022701CliP Partial Prosthesis TitaniumHeinz Kurz GmbHETB2023-09-29