DEVICE: Jacoti Listen App (05407004250014)
Device Identifier (DI) Information
Jacoti Listen App
Jacoti Listen App 2.X
In Commercial Distribution
Jacoti
Jacoti Listen App 2.X
In Commercial Distribution
Jacoti
Jacoti Listen App 2.X
Device Characteristics
Labeling does not contain MRI Safety Information | |
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No | |
No | |
No | |
No | |
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No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
30082 | Air-conduction hearing aid, wearable case |
A 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 microphone, an amplifier, and a speaker (receiver) contained in a case worn on the body (e.g., in a pocket or on a belt). 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 through an earmould connected to the case by a cord. Because it's relatively large size permits high amplification, this device has been used for profound hearing loss; it has largely been replaced with behind-the-ear (BTE) devices.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
ESD | Hearing Aid, Air-Conduction, Prescription |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
472cc4a0-3d17-4533-8e1a-c3975dc86859
January 09, 2023
1
December 30, 2022
January 09, 2023
1
December 30, 2022
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+9999999999
info@jacoti.com
info@jacoti.com