OtoNova Pro Clinical
OtoNova Pro Clinical is a portable, battery-powered hearing test system that measures otoacoustic emissions, the small sounds produced by the inner ear in response to sound stimulation.…
OtoNova Pro Clinical is a portable, battery-powered hearing test system that measures otoacoustic emissions, the small sounds produced by the inner ear in response to sound stimulation. Audiologists and other professionals skilled in audiology use clinical OAE analysis to characterize and monitor peripheral auditory function in patients of any age.
An ear probe delivers low-level sounds and records the acoustic response with a microphone. The device combines repeated responses and analyzes the signal and noise, then sends the results to Nova-Link software on a separate computer or Android tablet.
Clinical Controls
The Clinical application level provides detailed OAE analysis across a selectable frequency range at configurable stimulus levels, alongside screening functions. OtoNova Pro is controlled wirelessly and has two probe connectors. Clinical OAE findings form part of an assessment alongside other audiometric tests.
Who Else Makes It
All of them in Zhejiang.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Fastsound Acoustic Technology (Hangzhou) Co., Ltd. | Hangzhou | Zhejiang | Manufacturer | 6 |
| Zoomax Technology Co., Limited | Hangzhou | Zhejiang | Contract manufacturer | 5 |
Record
| Listed by | Otodynamics, Ltd., United Kingdom |
|---|---|
| FDA product code | EWO |
| Device type | Audiometer |
| Device class | Class 2 |
| Regulation | 21 CFR 874.1050 |
| Establishment | Manufacturer |
| 510(k) | K234095 |
| Record published | 2024-08-20 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| NPRO-CLN-D | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| RadioEar A/S | Interacoustics A/S | 131 |
| GN Otometrics A/S | Natus Medical Denmark ApS | 88 |
| Audiometer | Etymotic Research, Inc. | 73 |
| Siemens | WS Audiology USA, Inc. | 57 |
| Bio-logic | Natus Medical Incorporated | 33 |
| Welch Allyn, Inc. | Welch Allyn, Inc. | 29 |
| Real-EAR | WS Audiology USA, Inc. | 26 |
| Sanibel Supply A/S | Interacoustics A/S | 18 |
| Natus | Natus Medical Incorporated | 14 |
| Grason-Stadler | Diagnostic Group LLC | 12 |
| Interacoustics | Interacoustics A/S | 12 |
| Oscilla | Inmedico A/S | 12 |
Showing 12 of 348. All products under Audiometer
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K234095 | 2024-06-21 |
| K240430 | 2024-03-15 |
| K143395 | 2015-02-23 |
| K072033 | 2007-11-13 |
| K983350 | 1998-12-11 |
| K983352 | 1998-12-11 |
| K983351 | 1998-12-11 |
| K962995 | 1997-01-10 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.