(257 days)
K 982878, K 021867
Not Found
No
The description focuses on standard audiometry principles, software control of sound output, user response processing, and comparison to WHO guidelines. There is no mention of AI/ML algorithms for data analysis, interpretation, or decision-making beyond basic computation and comparison to predefined thresholds.
No.
The documentation states that the device is a "hearing screener" and its purpose is to "profile your hearing ability." It provides a "recommendation for potential hearing aid use," but it does not claim to treat, mitigate, or cure any condition.
Yes
The device is described as a "hearing screener for profiling your hearing ability" and measures "the individual's hearing level at each test frequency," ultimately providing a "recommendation for potential hearing aid use." This process of identifying or categorizing a health condition (hearing ability) aligns with the definition of a diagnostic device, even if it is a screening tool.
No
The device description explicitly states that the iHearTest Software System includes the "iHearUSB device" and "Factory calibrated in-ear earphones," which are hardware components. The software controls these hardware components to perform the hearing screening.
Based on the provided information, the iHearTest is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to obtain information for diagnostic or monitoring purposes.
- iHearTest Function: The iHearTest is a hearing screener that uses air-conducted sounds to assess a person's hearing ability. It does not involve the collection or analysis of any biological specimens from the body. It directly interacts with the user's auditory system.
Therefore, the iHearTest falls under the category of a medical device, but specifically a hearing screener, not an IVD.
N/A
Intended Use / Indications for Use
The iHearTest is an air-conduction over the counter hearing screener for profiling your hearing ability based on guidelines by the World Health Organization (WHO). The iHearTest is intended for home use by adults of at least 18 years of age. Hearing test results are displayed on the computer screen and stored in our HIPAA-compliant remote server for review anytime using secure online access.
The online iHearTest is intended for the adult consumer to provide basic hearing screening in the convenience of home or office.
Product codes
EWO
Device Description
The iHearTest is an over the counter (OTC) hearing screener for profiling hearing ability based on guidelines by the World Health Organization (WHO). The iHearTest is intended for home use by adults of at least 18 years of age.
The iHearTest Software System consists of:
- The iHearUSB device for connection to a personal computer via USB port. ●
- Factory calibrated in-ear earphones, marked for right and left ears, with 3 tip sizes. .
- iHearTest software application.
- . Instructions and warranty information provided in the User Guide and online.
- A quick Install guide to assist in the initial software installation, registering the USB ● device, and initiating the iHearTest.
The iHearTest Software System requires a standard personal computer (PC) with USB port running Microsoft Windows or OS X. The iHearTest software application is a browser-based software application executed from the consumer's personal computer that provides the user interface for a hearing screening test on the PC's monitor, controls the output of test sound signals from an iHearUSB device connected to the PC's USB port, displays hearing test results and sends the results to a remote HIPAA compliant server for review anytime by the consumer using secure online access, and conducts periodic checks of earphone calibration via the calibration tool incorporated into the iHearUSB device.
The User Guide and the online instructions instruct the individual in operations and functions. The individual follows the instructions to initiate and proceed with the hearing screening procedure.
The iHearTest kit is designed to produce air-conducted sounds via the in-ear earphone within the supra-threshold range of 25-85 dB HL at test frequencies of 500, 1000, 2000 and 4000 Hz. The iHearTest software application prompts the user to respond to test sounds and determines the individual's hearing level at each test frequency. The user's overall hearing ability is then computed and displayed for both the right and left ear with a recommendation for potential hearing aid use as per WHO guidelines. The user is provided, both online and in the User Guide, with disclaimers and safety information pertaining to the iHearTest. If a contraindication exists, the consumer must submit a physician-signed Medical Clearance prior to proceeding with the hearing screening.
The iHearUSB device incorporates a microphone for sensing the background noise during the hearing screening process, and ensuring that the background noise is within an acceptable level range.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Ear
Indicated Patient Age Range
adults of at least 18 years of age.
Intended User / Care Setting
home use by adults, home or office
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
An Institutional Review Board (IRB)-approved clinical study was conducted to assess the safety and efficacy of the iHearTest as a home air-conduction hearing screener. The study included 96 subjects (192 ears): 54 males and 42 females, ages 22-90 years with median age of 52. The iHearTest scoring results were compared to World Health Organization (WHO) grading of hearing impairment using standard practice audiometry. The study targeted adult subjects with known or suspected hearing loss.
Summary of Performance Studies
Clinical Study Summary:
An Institutional Review Board (IRB)-approved clinical study was conducted to assess the safety and efficacy of the iHearTest as a home air-conduction hearing screener. The study included 96 subjects (192 ears): 54 males and 42 females, ages 22-90 years with median age of 52. The iHearTest scoring results were compared to World Health Organization (WHO) grading of hearing impairment using standard practice audiometry. The study targeted adult subjects with known or suspected hearing loss. The primary objective of the iHearTest clinical study was to determine identification of disabling hearing impairment (corresponding to WHO levels 2-4), and the extent to which the iHearTest agreed with the WHO method for determining hearing impairment. The clinical study results showed 96.4% agreement with the WHO method using standard practice audiometry for the assessment of disabling hearing impairment, with sensitivity and specificity of 95% and 97%, respectively. For the ordinal assessment of hearing ability, the iHearTest showed 85.9% level-by-level (WHO grades of 0-4) agreement and 100% agreement within ±1 level with respect to WHO grading using standard practice instruments. The 14.1% variability in ordinal assessment for the iHearTest with respect to the standard practice method was consistent with the 13.5% variability across two standard practice audiometry methods evaluated in the study.
In addition to determining agreement with the WHO method using standard practice audiometry, the usability of the iHearTest system was also evaluated to obtain comments on the subjective experience with the iHearTest device, its packaging, software installation and setup. The iHearTest was found to be safe and effective as an over-the-counter hearing screening device.
Key Metrics
96.4% agreement with the WHO method using standard practice audiometry for the assessment of disabling hearing impairment, with sensitivity and specificity of 95% and 97%, respectively. For the ordinal assessment of hearing ability, the iHearTest showed 85.9% level-by-level (WHO grades of 0-4) agreement and 100% agreement within ±1 level with respect to WHO grading using standard practice instruments.
Predicate Device(s)
Maico MA1 Handheld Audiometer, Earscan 3 Screening Audiometer (K 982878), InSound HandFit (K 021867)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized eagle or bird in flight, composed of three human profiles facing to the right.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 29, 2015
iHear Medical, Inc. Ms. Angela Foreman Director, Quality Assurance & Regulatory Affairs 15250 Hesperian Blvd. Ste. #102 San Leandro, CA 94578
Re: K151025
Trade/Device Name: iHearTest Regulation Number: 21 CFR 874.1050 Regulation Name: Audiometer Regulatory Class: Class II Product Code: EWO Dated: November 17, 2015 Received: December 2, 2015
Dear Ms. Foreman:
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 general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
1
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made 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): medical device reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet
address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go
to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet
address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Srinivas Nandkumar -S
for 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
2
Indications for Use
510(k) Number (if known) K151025
Device Name iHearTest
Indications for Use (Describe)
The iHearTest is an air-conduction over the counter hearing screener for profiling your hearing ability based on guidelines by the World Health Organization (WHO). The iHearTest is intended for home use by adults of at least 18 years of age. Hearing test results are displayed on the computer screen and stored in our HIPAA-compliant remote server for review anytime using secure online access.
Type of Use (Select one or both, as applicable)
| Production Use (Part 21 CFR 601 Subpart E) |
|---|
| Compassionate Use (21 CFR 601 Subpart E) |
| | Prescription Use (Part 21 CFR 801 Subpart D)
|X | Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) SUMMARY
| Date Prepared: | December 21, 2015 |
|---|---|
| ---------------- | ------------------- |
Submitter Information:
| Company Name: | iHear Medical Inc. |
|---|---|
| Company Address: | 15250 Hesperian Blvd. Suite #102 |
| San Leandro, CA 94578 | |
| Contact Person: | Angela Lee Foreman, Ph.D., Director, QA/RA |
| iHear Medical, Inc. | |
| Tel: (510) 276-4437 | |
| Fax: (510) 686-8560 | |
| e-mail: angela@ihearmedical.com |
De vice Information:
| Trade Name: | iHearTest |
|---|---|
| Common Name: | Hearing Screener, Audiometer |
| Classification Name: | Audiometer |
| Device Class/Code: | Class II Exempt, EWO |
| Regulation Number: | 21 CFR §874.1050 |
| Type of 510(k): | Traditional |
Predicate Devices:
-
- Maico MA1 Handheld Audiometer, (Establishment # 2113281) Maico Diagnostics, Exempt under 21 CFR §874.1050
-
- Earscan 3 Screening Audiometer (K 982878) Micro Audiometric Corp.; approved for marketing on November 3, 1998
-
- InSound HandFit (K 021867) InSound Medical, part of the InSound XT Hearing Aid and HandFit system, approved for marketing on November 19, 2002
4
K151025 iHearTest
Device Description: The iHearTest is an over the counter (OTC) hearing screener for profiling hearing ability based on guidelines by the World Health Organization (WHO). The iHearTest is intended for home use by adults of at least 18 years of age.
The iHearTest Software System consists of:
- The iHearUSB device for connection to a personal computer via USB port. ●
- Factory calibrated in-ear earphones, marked for right and left ears, with 3 tip sizes. .
- iHearTest software application.
- . Instructions and warranty information provided in the User Guide and online.
- A quick Install guide to assist in the initial software installation, registering the USB ● device, and initiating the iHearTest.
The iHearTest Software System requires a standard personal computer (PC) with USB port running Microsoft Windows or OS X. The iHearTest software application is a browser-based software application executed from the consumer's personal computer that provides the user interface for a hearing screening test on the PC's monitor, controls the output of test sound signals from an iHearUSB device connected to the PC's USB port, displays hearing test results and sends the results to a remote HIPAA compliant server for review anytime by the consumer using secure online access, and conducts periodic checks of earphone calibration via the calibration tool incorporated into the iHearUSB device.
The User Guide and the online instructions instruct the individual in operations and functions. The individual follows the instructions to initiate and proceed with the hearing screening procedure.
The iHearTest kit is designed to produce air-conducted sounds via the in-ear earphone within the supra-threshold range of 25-85 dB HL at test frequencies of 500, 1000, 2000 and 4000 Hz. The iHearTest software application prompts the user to respond to test sounds and determines the individual's hearing level at each test frequency. The user's overall hearing ability is then computed and displayed for both the right and left ear with a recommendation for potential hearing aid use as per WHO guidelines. The user is provided, both online and in the User Guide, with disclaimers and safety information pertaining to the iHearTest. If a contraindication exists, the consumer must submit a physician-signed Medical Clearance prior to proceeding with the hearing screening.
The iHearUSB device incorporates a microphone for sensing the background noise during the hearing screening process, and ensuring that the background noise is within an acceptable level range.
Indications for Use: The iHearTest is an air conduction over the counter hearing screener for profiling your hearing ability based on guidelines by the World Health Organization (WHO). The iHearTest is intended for home use by adults of at least 18 years of age. Hearing test results
5
K151025 iHearTest
are displayed on the computer screen and stored in our HIPAA-compliant remote server for review anytime using secure online access.
Intended Use: The online iHearTest is intended for the adult consumer to provide basic hearing screening in the convenience of home or office.
Comparison to Predicate Device: Device features and parameters are similar for the iHearTest, which is the subject of this 510(k) Notification, and the aforementioned predicate devices. The intended use (including patient population) for the iHearTest is mostly consistent with the cited predicate devices in terms of technological characteristics (i.e., design, material, and sound emissions). The iHearTest is designed for self-administration by the adult consumer; it is not a diagnostic tool for the professional health care provider.
Performance testing:
Verification testing was conducted on the iHearTest software and the iHearUSB firmware to confirm the correct functioning of the Software System as described above, including correct output of sounds at test frequencies of 500, 1000, 2000 and 4000 Hz. Even when other Windows programs/apps were running in parallel. Also manipulation of Windows audio output settings were verified to not affect the intended sound output, consistent with the design of the iHear system.
Earphones were confirmed to be factory-calbrated using industry standard callbration tools, and are confirmed to maintain calibration after simulated aging and weathering tests.
The iHearUSB device's built-in calibration tool is confirmed to have identical calibration test results as industry standard calibration tools both at the time of manufacturing and after simulated aging and weathering tests.
Engineering validation was performed to demonstrate performance in accordance with recognized standards for this type of device, namely ANSI S3.6-2010 Type 4 air-conduction audiometer and the World Health Organization (WHO) guidelines for determination of hearing impairment.
Clinical Study Summary:
An Institutional Review Board (IRB)-approved clinical study was conducted to assess the safety and efficacy of the iHearTest as a home air-conduction hearing screener. The study included 96 subjects (192 ears): 54 males and 42 females, ages 22-90 years with median age of 52. The iHearTest scoring results were compared to World Health Organization (WHO) grading of hearing impairment using standard practice audiometry. The study targeted adult subjects with known or suspected hearing loss. The primary objective of the iHearTest clinical study was to determine identification of disabling hearing impairment (corresponding to WHO levels 2-4), and the extent to which the iHearTest agreed with the WHO method for determining hearing impairment. The clinical study results showed 96.4% agreement with the WHO method using
6
K151025 iHearTest
standard practice audiometry for the assessment of disabling hearing impairment, with sensitivity and specificity of 95% and 97%, respectively. For the ordinal assessment of hearing ability, the iHearTest showed 85.9% level-by-level (WHO grades of 0-4) agreement and 100% agreement within ±1 level with respect to WHO grading using standard practice instruments. The 14.1% variability in ordinal assessment for the iHearTest with respect to the standard practice method was consistent with the 13.5% variability across two standard practice audiometry methods evaluated in the study.
In addition to determining agreement with the WHO method using standard practice audiometry, the usability of the iHearTest system was also evaluated to obtain comments on the subjective experience with the iHearTest device, its packaging, software installation and setup. The iHearTest was found to be safe and effective as an over-the-counter hearing screening device.
In summary, subjects tested included both male and female adult participants, of the appropriate age range, and varied hearing impairment levels (i.e., subjects with normal hearing and mild to severe impairment). No adverse effects or complications were observed. The performance data collected supports a substantial equivalence determination.
Safety: The design of the iHearTest device provides safety to the individual user. To prevent the unlikely possibility of excessive exposure to high-level sound, hardware and software were implemented to limit maximum sound output to below 90 dB HL. The iHearTest device has been designed to conform to the following performance and safety standards:
| ANSI S3.6-2010 | Specifications for Audiometers, American National
Standards Institute |
|------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| EN/IEC 60601-1 | Medical electrical equipment: Part 1: General
requirements for safety |
| EN/IEC 60601-1-2 | Medical electrical equipment: Part 1: General
requirements for safety; Section 1-2 Collateral standard:
Electromagnetic compatibility - Requirements and tests |
Conclusion: The information and data provided in this 510(k) Notification establish that the iHearTest device with the online test performed by the consumer using his/her home computer is substantially equivalent to the aforementioned legally marketed predicate devices.