Reported Feb 26, 2014 · Terminated

Siemens Prisma 2K Hearing Aid Product Usage: A behind the ear (BTE) hearing aid developed for pediatric patients.

Siemens Hearing Instruments, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Siemens Hearing Instruments, Inc · 10 Constitution Ave · Piscataway, NJ · 08855

Is this the product you have?

  • Siemens
  • Prisma 2K Hearing Aid Product UsageA behind the ear (BTE) hearing aid developed for pediatric patients
Lot codes and dates
  • Part numbers 1) 7773182 2) 7244028 3) 8757374 4) 8747086 5) 10056937 6) 10056938
Amount recalled
738 units

Where it was sold

  • Nationwide

Why it was recalled

Siemens became aware of an issue where an infant or child could open the tamper resistant battery compartment of the Siemens Prisma 2K hearing aid under certain unintended use conditions.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Jul 6, 2017 · Data as of Sep 19, 6:18 PM UTC

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