MAUDE Adverse Event Report: SONOVA AG PHONAK AUDEO LUMITY HEARING AID (L70-RIC DIGITIAL); HEARING AID, AIR-CONDUCTION WITH WIRELESS TECHNOLOGY, PRESCRIPTION

Health Effect - Clinical Codes	Sore Throat (2396); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	06/15/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
I had noticed a correlation between wearing my new phonak hearing aids and sore throats.This got worse over time, leading to hoarseness and a nearly complete loss of voice.Unable to find any information on this from my audiologist or on audiology and phonak websites, i found several references to this adverse effect on medical websites, including webmd, nih, and cleveland clinic, stating clearly that this comes from stimulation of the vagus nerve by the hearing aid.When presented with this finding, phonak gave me a full refund, despite being well past the "trial" period.That says a lot.However, i don't think many people will make the connection between their hearing aids and their throat and larynx, perhaps doing serious harm over time (likely the same as smoking), and the industry is clearly concealing this health and safety issue.I would like it to be known.It became clear, after the fact, that my audiologist knew about this risk all along.

• Brand Name: PHONAK AUDEO LUMITY HEARING AID (L70-RIC DIGITIAL)
• Common Device Name: HEARING AID, AIR-CONDUCTION WITH WIRELESS TECHNOLOGY, PRESCRIPTION
• Manufacturer (Section D): SONOVA AG
• MDR Report Key: 20246824
• Report Number: MW5159682
• Device Sequence Number: 15372814
• Product Code: OSM
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 09/13/2024

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?: Yes
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/17/2024
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ASPIRIN.; CLONAZEPAM.; DAILY MULTIVITAMIN.; EZETIMIBE.; LOSARTAN.; OVER THE COUNTER - ONE A DAY WOMEN'S.; PREMARIN VAGINAL CREAM.
• Outcome Attributed to Adverse Event: Disability
• Patient Age: 72 YR
• Patient Sex: Female
• Patient Weight: 59 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White