(86 days)
Not Found
No
The description mentions an "automated hearing threshold estimation algorithm" and "signal statistics" for evaluation, but there is no mention of AI, ML, or related terms like neural networks or deep learning. The technology described is based on established OAE techniques and pure tone audiometry.
No.
The device is described as an examination system intended for hearing assessment, diagnosis of hearing disorders, and assisting in hearing aid selection/first-fit. It does not provide treatment or therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "intended for use in diagnostic hearing evaluations and assistance in the diagnosis of possible hearing disorders."
No
The device description explicitly states "Cochlea-Scan is a hand-held examination system based on Otoacoustic Emissions (OAE) technology" and mentions it is equipped with a "standard pure tone audiometer," indicating it includes hardware components for generating and measuring sound.
Based on the provided information, the Cochlea Scan is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the human body. The Cochlea Scan is a device that interacts directly with the ear to measure otoacoustic emissions (OAEs) and perform pure tone audiometry. It does not analyze biological samples like blood, urine, or tissue.
- The intended use and device description clearly indicate a direct interaction with the patient's ear. The device is used for hearing assessment and diagnosis based on responses from the auditory system, not on the analysis of a collected sample.
Therefore, the Cochlea Scan falls under the category of a medical device, but not specifically an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
- The Cochlea Scan is intended for use in automated objective hearing assessment using 1. distortion product OAEs.
- The Cochlea Scan is intended for use in diagnostic hearing evaluations and assistance in the 2. diagnosis of possible hearing disorders by means of OAEs and/or pure tone audiometry. Hearing disorders include middle ear and cochlear hearing losses.
- The results of the Cochlea Scan can be used to assist in the selection and/or (first-) fit of 3. conventional hearing aids. It does not provide data for prescribing or fitting cochlear implants or middle ear implants.
- The Cochlea Scan is intended for use in hearing screening using OAEs (with optional TEOAE 4. module).
Product codes (comma separated list FDA assigned to the subject device)
EWO
Device Description
Cochlea-Scan is a hand-held examination system based on Otoacoustic Emissions (OAE) technology. Identical techniques are used - among others - on Fischer-Zoth model Echo-Screen. The Cochlea-Scan product family is designed easy to use and employs automated OAE. The measurement flow is menu quided and the evaluation is based upon signal statistics. The Cochlea-Scan devices are designed for trained personnel in a medical or school environment to examine hearing in newborns through adults, including geriatric patients. With its built-in automated hearing threshold estimation algorithm the device does not measure hearing per se, but helps to determine whether or not a hearing loss may be present and in case of hearing loss proposes an estimation of the hearing threshold in a given frequency range. Additionally Cochlea-Scan is equipped with a standard pure tone audiometer.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
newborns through adults, including geriatric patients.
Intended User / Care Setting
trained personnel in a medical or school environment
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 874.1050 Audiometer.
(a)
Identification. An audiometer or automated audiometer is an electroacoustic device that produces controlled levels of test tones and signals intended for use in conducting diagnostic hearing evaluations and assisting in the diagnosis of possible otologic disorders.(b)
Classification. Class II. Except for the otoacoustic emission device, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, if it is in compliance with American National Standard Institute S3.6-1996, “Specification for Audiometers,” and subject to the limitations in § 874.9.
0
KC6174YY
510(k) Summary of Safety and Effectiveness
| | 510(k) Summary of Safety and Effectiveness
as required by section 807.92 (c) | SEP 15 2006 |
|-------------------------------------------|---------------------------------------------------------------------------------------------|-------------|
| Submitters Name and Address: | Bio-logic Systems Corp.,
(a Natus company)
One Bio-logic Plaza
Mundelein, IL 60060 | |
| Contact Person & Phone: | Mr. Norman Brunner
(847) 949 5200 ext. -224 | |
| Date Summary Prepared: | May 05th, 2006 | |
| Device Name:
Proprietary / Trade name: | Classification name - Audiometer, EWO
Cochlea-Scan / Cochlea-Scan Plus | |
| Predicate Device: | Fischer-Zoth, model Echo-Screen: 510(k) K013977 | |
Device description:
Cochlea-Scan is a hand-held examination system based on Otoacoustic Emissions (OAE) technology. Identical techniques are used - among others - on Fischer-Zoth model Echo-Screen. The Cochlea-Scan product family is designed easy to use and employs automated OAE. The measurement flow is menu quided and the evaluation is based upon signal statistics. The Cochlea-Scan devices are designed for trained personnel in a medical or school environment to examine hearing in newborns through adults, including geriatric patients. With its built-in automated hearing threshold estimation algorithm the device does not measure hearing per se, but helps to determine whether or not a hearing loss may be present and in case of hearing loss proposes an estimation of the hearing threshold in a given frequency range. Additionally Cochlea-Scan is equipped with a standard pure tone audiometer.
Intended use:
- The Cochlea Scan is intended for use in automated objective hearing assessment using 1. distortion product OAEs.
- The Cochlea Scan is intended for use in diagnostic hearing evaluations and assistance in the 2. diagnosis of possible hearing disorders by means of OAEs and/or pure tone audiometry. Hearing disorders include middle ear and cochlear hearing losses.
- The results of the Cochlea Scan can be used to assist in the selection and/or (first-) fit of 3. conventional hearing aids. It does not provide data for prescribing or fitting cochlear implants or middle ear implants.
- The Cochlea Scan is intended for use in hearing screening using OAEs (with optional TEOAE 4. module).
Technological Characteristics:
- miniature probe, easy to apply even for premature infants, identical Probe: to the probe used on the predicate device Echo-Screen -Headphone: standard audiometry headphone with calibration data stored in customized connector
1
Docking station label (50 mm x 20 mm):
| Docking station | FZ |
|---|---|
| ----------------- | ---- |
| USE ONLY CHARGER | FW7206/09 |
|---|---|
| ------------------ | ----------- |
Follow safety hints!
Sicherheitshinweise beachten!
Suivez attentivement les instrucions d'usage!
Seguire le istruzioni per la sicurezza!
Operation manual
See Appendix A
Advertising and Promotional Materials
Bio-logic intends to promote and market the Cochlea-Scan in professional and trade publications, through marketing materials, and at trade shows and professional organization meetings. The advertising and promotional materials will incorporate the product design, product specifications, and product claims as described in this 510(k) submission.
All advertising and promotional materials will comply with the following statement of intended use:
The Cochlea Scan is intended for use in automated objective hearing assessment using distortion product OAEs.
The Cochlea Scan is intended for use in diagnostic hearing evaluations and assistance in the diagnosis of possible hearing disorders by means of OAEs and/or pure tone audiometry. Hearing disorders include middle ear and cochlear hearing losses.
The results of the Cochlea Scan can be used to assist in the selection and/or (first-) fit of conventional hearing aids. It does not provide data for prescribing or fitting cochlear implants or middle ear implants.
The Cochlea Scan is intended for use in hearing screening using OAEs (with optional TEOAE module).
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines. The symbol is stylized and modern, representing the department's mission and values.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FP 1 5 2006
Bio-Logic Systems Corp. c/o Mr. Norman Brunner One Biologic Plaza Mundelein, IL 60060-3700
Re: K061744
Trade/Device Name: Cochlea-Scan/Cochlea-Scan Plus Regulation Number: 21 CFR 874.1050 Regulation Name: Audiometer Regulatory Class: II Product Code: EWO Dated: August 18, 2006 Received: August 21, 2006
Dear Mr. Brunner:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The r va may, atere, which of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it 11 your device to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean r lease be actives mark a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
Page 2 – Mr. Norman Brunner
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
M.B. Egelman SimMD
Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
INDICATIONS FOR USE STATEMENT
K061744 510(k) Number (if known):
Device Name: Cochlea Scan.
Indications For Use:
-
- The Cochlea Scan is intended for use in automated objective hearing assessment using distortion product OAEs.
- 2 The Cochlea Scan is intended for use in diagnostic hearing evaluations and The Cochiea Soan is finchuod for able hearing disorders by means of OAEs and/or assistance in the alaghous of possorders include middle ear and cochlear hearing losses.
- The results of the Ocenica ads. It does not provide data for prescribing or fitting cochlear implants or middle ear implants.
-
- The Cochlea Scan is intended for use in hearing screening using OAEs (with optional TEOAE module).
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
TVC
(Unvision Sign-C Division of Ophthalmic E Nose and Throat Devis 510(k) Numbe
Prescription Use ✓
OR
Over-The-Counter Use
(Optional Format 1-2-96)
510(k) CochleaScan.doc
(Per 21 CFR 801.109)