Siemens Hearing Instruments, Inc.
United StatesFDA applicant, unverified
- Devices
- 42
- FDA recalls
- 1
At a glance
Market reach
- United States
- FDA recalls
What Siemens Hearing Instruments, Inc. makes
Siemens Hearing Instruments, Inc. manufactures behind-the-ear hearing instruments, including programmable models with single-band and full dynamic range compression. Their portfolio also includes tinnitus control instruments, audiometers with probe microphone systems, and silicone impression materials for custom fittings. Additional offerings include pocket hearing instruments and accessories like probe systems for diagnostic use.
The company’s devices are classified under FDA categories Class I and Class II, with regulatory submissions recorded in the FDA’s 510(k) database. Products are listed under U.S. jurisdiction, adhering to applicable medical device regulations. The manufacturer operates from the United States.
Catalogue
Search and filter all 42 devicesFDA recalls
FDA recall records list 1 recall initiated by Siemens Hearing Instruments, Inc., initiated on 2005-07-01. By recorded status: 1 terminated. The reasons filed fall into these groups: electrical or power. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2005
- 1 Jul 2005 Z-0988-2014 Class II Terminated 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.
Frequently asked questions
How many devices does Siemens Hearing Instruments, Inc. have in the registry?
The registry currently lists 42 devices for Siemens Hearing Instruments, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Siemens Hearing Instruments, Inc.'s devices?
Among its 42 most recently registered devices, Siemens Hearing Instruments, Inc. has devices listed in FDA 510(k) (42 devices).
What risk classes do Siemens Hearing Instruments, Inc.'s devices fall under?
Among its 42 most recently registered devices, the classes recorded for Siemens Hearing Instruments, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Siemens Hearing Instruments, Inc.?
FDA recall records list 1 recall initiated by Siemens Hearing Instruments, Inc., the most recent initiated on 1 Jul 2005. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Siemens Hearing Instruments, Inc. in the registry?
The most recently registered devices listed for Siemens Hearing Instruments, Inc. include PROGRAMMABLE TWO MEMORY, SINGLE BAND BEHIND THE EAR HEARING INSTRUMENT, INTELIVENIENCE PROGRAMMABLE FULL DYNAMIC RANGE COMPRESSION BEHIND THE EAR HEARING INSTRUMENT, FULL DYNAMIC RANGE COMPRESSION BEHIND THE EAR HEARING INSTRUMENT and TCI (TINNITUS CONTROL INSTRUMENT).