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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 078-0071
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Ear infection (4813)
Type of Reportable Event Serious Injury
Event or Problem Description
It has been brought to manufacturer's attention that lyric device was removed after 46 wear days.Upon the removal the hcp observed significant white/off white pus with significant odour, possible infection - ent referral.
 
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Brand Name
PHONAK LYRIC4
Common Device Name
AIR-CONDUCTION HEARING AID, IN-CANAL
Manufacturer (Section D)
SONOVA AG
laubisruetistrasse 28
staefa, zurich, che 8712
SZ  8712
MDR Report Key24333616
Report Number3008848788-2026-00001
Device Sequence Number9773506
Product Code ESD
UDI-Device Identifier07613389603316
UDI-Public(01)07613389603316
Combination Product (Y/N)N
Initial Reporter StateNY
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) 01/16/2026
Report Date (Section F) 01/16/2026
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 Lay User/Patient
Device Model Number078-0071
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date01/16/2026
Device Age6 MO
Event Location Home
Date Report to Manufacturer01/16/2026
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date02/13/2026
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 SexFemale
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