FDA Adverse Event Injury Summary report: N

HEARING AID BATTERY

MDR report key: 23439026 · Received October 31, 2025

Report

Report Number
MW5178396
Event Type
Injury
Date Received
October 31, 2025
Date of Event
March 19, 2025
Report Date
October 28, 2025
Manufacturer
UNK
Product Code
QUF
Adverse Event
Yes
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
TX, US
Reporter Occupation
PATIENT
Health Professional
*

Narratives

Description of Event or Problem · 0

IN RECENT MONTHS, NEW "CHILD-RESISTANT" PACKAGING FOR HEARING AID BATTERIES HAS BEEN IMPLEMENTED, AND IT HAS CREATED SERIOUS USABILITY AND SAFETY PROBLEMS FOR MANY PEOPLE WHO RELY ON HEARING AIDS. THE PACKAGING IS EXTREMELY DIFFICULT TO OPEN -- REQUIRING EXCESSIVE FORCE, TWISTING, OR PULLING -- WHICH HAS LED TO MINOR INJURIES SUCH AS CUTS, BROKEN NAILS, AND SKIN IRRITATION FOR MYSELF AND MANY OTHER HEARING AID USERS. AS SOMEONE WHO DEPENDS ON HEARING AIDS DAILY, I'VE PERSONALLY STRUGGLED TO OPEN THE NEW PACKAGING SAFELY. THE DESIGN REQUIRES STRONG GRIP STRENGTH AND FINE MOTOR CONTROL, WHICH MANY HEARING AID USERS, ESPECIALLY OLDER ADULTS OR THOSE WITH DEXTERITY LIMITATIONS, DO NOT HAVE. IN SEVERAL ONLINE DISCUSSIONS AND CONSUMER REVIEWS, THOUSANDS OF PEOPLE HAVE REPORTED THE SAME ISSUE, STATING THAT THE PACKAGING IS "ADULT-PROOF" RATHER THAN CHILD-PROOF. WHILE I UNDERSTAND THE IMPORTANCE OF CHILD SAFETY, THIS PACKAGING HAS GONE TOO FAR IN THE OTHER DIRECTION. HEARING AID USERS ARE A VULNERABLE POPULATION WHO ALREADY FACE ACCESSIBILITY CHALLENGES, AND THIS NEW DESIGN HAS MADE IT HARDER TO PERFORM A SIMPLE, ESSENTIAL TASK -- REPLACING A HEARING AID BATTERY. IN MY OWN EXPERIENCE, I HAVE ACCIDENTALLY SCRATCHED AND PINCHED MY FINGERS MULTIPLE TIMES WHILE TRYING TO REMOVE BATTERIES FROM THE PACKAGING, AND I'VE SEEN OTHERS POST ABOUT SIMILAR INJURIES OR FRUSTRATION. THIS PACKAGING ISSUE NOT ONLY CAUSES PHYSICAL INJURY BUT ALSO REDUCES INDEPENDENCE AND ACCESSIBILITY FOR PEOPLE WHO RELY ON HEARING AIDS TO COMMUNICATE AND FUNCTION IN DAILY LIFE. MANY USERS HAVE EXPRESSED THAT THEY NOW REQUIRE ASSISTANCE FROM FAMILY MEMBERS JUST TO OPEN THEIR BATTERIES, WHICH SHOULD NOT BE THE CASE. I AM REPORTING THIS TO REQUEST THAT THE FDA REVIEW THIS PACKAGING REQUIREMENT AND WORK WITH THE CONSUMER PRODUCT SAFETY COMMISSION (CPSC) AND HEARING AID BATTERY MANUFACTURERS TO CREATE PACKAGING THAT REMAINS CHILD-SAFE WITHOUT MAKING IT UNSAFE OR INACCESSIBLE FOR ADULTS WHO ACTUALLY USE THE PRODUCT. THE CURRENT DESIGN PRESENTS A WIDESPREAD USABILITY AND MINOR INJURY PROBLEM THAT DESERVES REGULATORY ATTENTION.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
224878 HEARING AID BATTERY HEARING AID, AIR-CONDUCTION, OVER THE COUNTER QUF UNK

Patients

Seq Age Sex Outcome Treatment
1 19 YR Female Required Intervention