Intelligent Hearing Systems Corp.
Active in EUDAMEDUnited Statesfrom SRN EUDAMED FDA SRN US-MF-000011473 FEI 1000113738
Intelligent Hearing Systems Corp. is a medical device manufacturer based in the United States, with 127 devices listed in FDA GUDID, FDA 510(k) and EUDAMED (FDA Class II; EU Class IIa and I) and 1 FDA recall as of 12 Nov 2026.
- Devices
- 127
- Registrations
- EUDAMEDFDA
- FDA recalls
- 1
Registry facts
- Registries
- FDA GUDID 114
- FDA 510(k) 13
- EUDAMED 3
- Device classes
- FDA Class II 124
- EU Class IIa 2
- EU Class I 1
- Top EMDN categories
- FDA recalls
- Sites and related companies
- Emergo Europe B.V. authorised representative
- MedEnvoy Global BV authorised representative
- Identifiers
- EUDAMED SRN US-MF-000011473
- FDA FEI 1000113738
- DUNS 154870455
At a glance
EU certificates
1 of 1 in force.
Market reach
- European Union
- EUDAMED actor, 1 certificate
- United States
- FDA FEI, FDA recalls
- Authorised rep.
- Emergo Europe B.V.NL
- Authorised rep.
- MedEnvoy Global BVNL
What Intelligent Hearing Systems Corp. makes
Intelligent Hearing Systems Corp. manufactures analytical scalp leads, multiple physiological signal amplifiers, otoacoustic emission systems, visual-reinforcement-audiometry reward systems, evoked-potential graphic recording systems, bioelectrical signal analysis software, auditory cranial bone vibrators, and insert earphones.
The company's portfolio includes Class I, Class II, and Class IIa devices, listed in both EUDAMED and FDA UDI registries. Intelligent Hearing Systems Corp. is based in the US.
Catalogue
Search and filter all 127 devicesShowing 1-50 of 127
Company details
- EUDAMED SRN
- US-MF-000011473
- FDA FEI number
- 1000113738
- DUNS number
- 154870455
- EUDAMED status
- Active
- EUDAMED registered name
- Intelligent Hearing Systems Corp.
- EUDAMED abbreviated name
- IHS
- Registered address
- 6860 SW 81st Street, 33143, Miami, United States
- ihsys@ihsys.com
- PRRC contact
- Edward Miskiel
EUDAMED certificates
1 certificate1 valid, 0 expiredMDR 1next expiry 5 Jan 2028
DQS Medizinprodukte GmbH 0297 1 certificate
- 1000169849 Active
Quality management system EU MDR
- Issued
- 8 Apr 2024
- Expires
- 5 Jan 2028
- Reason
- Other
FDA recalls
FDA recall records list 1 recall initiated by Intelligent Hearing Systems Corp., initiated on 2008-10-21. By recorded status: 1 terminated. The reasons filed fall into these groups: other reasons as filed. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2008
- 21 Oct 2008 Z-1704-2010 Unclassified (pre-2012) Terminated This was a marketing correction mandated by the United States Food and Drug Administration (USFDA). USFDA notified Intelligent Hearing Systems that 501(k) premarket notification application must be submitted and cleared in order to market and sell devices with Vestibular Evoked Myogenic Potential (VEMP) specific functions. The Food and Drug Administration considers that the VEMP testing functions
Frequently asked questions
How many devices does Intelligent Hearing Systems Corp. have in the registry?
The registry currently lists 127 devices for Intelligent Hearing Systems Corp.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Intelligent Hearing Systems Corp.'s devices?
Among its 50 most recently registered devices, Intelligent Hearing Systems Corp. has devices listed in FDA GUDID (50 devices).
What risk classes do Intelligent Hearing Systems Corp.'s devices fall under?
Among its 50 most recently registered devices, the classes recorded for Intelligent Hearing Systems Corp.'s devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Intelligent Hearing Systems Corp.?
FDA recall records list 1 recall initiated by Intelligent Hearing Systems Corp., the most recent initiated on 21 Oct 2008. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What EUDAMED certificates are recorded for Intelligent Hearing Systems Corp.?
EUDAMED lists 1 certificate for Intelligent Hearing Systems Corp. (quality management system) under MDR. The most recent was issued on 8 Apr 2024.
What are the newest devices from Intelligent Hearing Systems Corp. in the registry?
The most recently registered devices listed for Intelligent Hearing Systems Corp. include Capella2 OAE Start-Up Kit 8-69-42800, SEP StartUp Kit - 1 Channel M019200, SEP StartUp Kit - 2 Channels M019201 and SEP StartUp Kit - 4 Channels M019202.