Intelligent Hearing Systems: FDA filings under this applicant name
FDA lists 13 510(k) clearances under the applicant name “Intelligent Hearing Systems” (first 1991, latest 2017), across 4 product codes in 2 review panels. Median 510(k) review time under this name: 90 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 1 | 305 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Intelligent Hearing Systems took a median 305 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 134 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GWJ | Stimulator, Auditory, Evoked Response | 8 | 8 |
| EWO | Audiometer | 2 | 2 |
| GWL | Amplifier, Physiological Signal | 2 | 2 |
| GXY | Electrode, Cutaneous | 1 | 1 |
Review panels
- Neurology (11)
- Ear, Nose and Throat (2)
Most recent Intelligent Hearing Systems 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K163326 | SmartEP | GWJ | 2017-09-29 | 305 |
| K090579 | SMARTSCREENER-PLUS2 | GWJ | 2009-07-07 | 126 |
| K073384 | SMART COUPLER, MODEL M015401 | GWJ | 2008-02-28 | 87 |
| K070608 | SMARTEP, MODEL M010000 | GWJ | 2007-07-18 | 135 |
| K063402 | WICK ELECTRODE, MODEL M019260 | GXY | 2006-12-11 | 32 |
| K061443 | SMART USBLITE, MODEL M011120 | GWJ | 2006-06-23 | 30 |
| K052060 | OPTI-AMP DC-POWERED | GWL | 2005-08-31 | 33 |
| K031051 | SMARTEP-ASSR, MODEL M811007 | GWJ | 2004-02-20 | 324 |
| K023859 | SMARTTROAE | EWO | 2003-01-08 | 49 |
| K964426 | SMARTOAE | EWO | 1997-02-03 | 90 |
3 earlier clearances. See the full list in Caduvo.
Recalls
1 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2008-10-21.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Device clinical trials
An industry sponsor named Intelligent Hearing Systems is the lead sponsor of 1 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT03971578: Screening for Autism Spectrum Disorders Using Auditory Brainstem Responses (Completed, started 2020-02-01)
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Intelligent Implant Systems, LLC (6 510(k)s)
- Intelligent Medical Devices, Inc. (4 510(k)s)
- Intelligent Medicine, Inc. (4 510(k)s)
- Intelligent Orthopaedics, Ltd. (3 510(k)s)
- Intelligent Images Srl (2 510(k)s)
- Intelligent Medical Systems (2 510(k)s)
- Intelligent Product Limited Co. (2 510(k)s)
- Intelligent Surgical Lasers, Inc. (2 510(k)s)
- Intelligent Ultrasound Limited (1 510(k)s)
- Intelligent Dots, LLC (1 510(k)s)
- Intelligent Endoscopy (1 510(k)s)
- Intelligent Instruments Pvt. , Ltd. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Intelligent Hearing Systems?
FDA lists 13 510(k) clearances under the applicant name “Intelligent Hearing Systems” (first 1991, latest 2017), across 4 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Intelligent Hearing Systems?
The median time from FDA receipt to decision across 510(k)s cleared under the name Intelligent Hearing Systems is 90 days.
Which FDA product codes appear under Intelligent Hearing Systems?
The most frequent FDA product codes under this applicant name are GWJ (Stimulator, Auditory, Evoked Response, 8); EWO (Audiometer, 2); GWL (Amplifier, Physiological Signal, 2).
Next steps
- See all 13 Intelligent Hearing Systems clearances with predicates and recalls
- Run predicate analysis for product code GWJ, Intelligent Hearing Systems's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.