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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SONOVA AG PHONAK LYRIC4; AIR-CONDUCTION HEARING AID, IN-CANAL
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SONOVA AG PHONAK LYRIC4; AIR-CONDUCTION HEARING AID, IN-CANAL Back to Search Results
Model Number 078-0072
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Unspecified Ear or Labyrinth Problem (4474)
Type of Reportable Event Serious Injury
Event or Problem Description
It has been brought to manufacturer's attention that there was a fitting/removal related issue with a lyric device.It is said the reason for device removal was migration and that sore and ulceration of tissue with severeness rated as mild was observed upon.
 
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Brand Name
PHONAK LYRIC4
Common Device Name
AIR-CONDUCTION HEARING AID, IN-CANAL
Manufacturer (Section D)
SONOVA AG
laubisrütistrasse 28
stafa, zurich ,che 8712
SZ  8712
MDR Report Key23790412
Report Number3008848788-2025-00020
Device Sequence Number12142996
Product Code ESD
UDI-Device Identifier07613389603323
UDI-Public(01)07613389603323
Combination Product (Y/N)N
Initial Reporter StateCA
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)N
Reporter Type Importer
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 11/13/2025
Report Date (Section F) 11/13/2025
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Operator of Device Health Professional
Device Model Number078-0072
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Distributor Facility Aware Date11/10/2025
Device Age4 MO
Event Location Other
Date Report to Manufacturer11/13/2025
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date12/12/2025
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Other;
Patient SexUnknown
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