Siemens Hearing Instruments, Inc Siemens Prisma 2K Hearing Aid Product Usage: A behind the ear (BTE) hearing aid developed for pediatric patients. Recall
Class II: A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Class II recall indicates potential for temporary health effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Siemens Prisma 2K Hearing Aid Product Usage: A behind the ear (BTE) hearing aid developed for pediatric patients.
Brand
Siemens Hearing Instruments, Inc
Lot Codes / Batch Numbers
Part numbers 1) 7773182 2) 7244028 3) 8757374 4) 8747086 5) 10056937 6) 10056938
Products Sold
Part numbers 1) 7773182 2) 7244028 3) 8757374 4) 8747086 5) 10056937 6) 10056938
Siemens Hearing Instruments, Inc is recalling Siemens Prisma 2K Hearing Aid Product Usage: A behind the ear (BTE) hearing aid developed for pe due to 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 und. This is a Class I recall, indicating a high risk of serious health consequences or death. Based on FDA medical device enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
Healthcare providers and patients should stop using the device and contact the manufacturer for further instructions. Report problems to FDA MedWatch.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 11, 2026