The 1E-Zen program is intended to provide a relaxing sound background for adults (21 years and older) who desire to listen to such a background in quiet. It may be used as a sound therapy tool in a tinnitus treatment program that is programmed by a licensed hearing healthcare professional (audiologists, hearing aid specialists, otolaryngologists) who is trained in tinnitus management.

The IE-Zen program is intended to be used in quiet where hearing everyday sounds is not critical.

Device Description

The CLEAR series hearing aids (including CLEAR440. CLEAR330. CLEAR220 and super-power SUPER440 and SUPER220 - also privately labeled as REVIVE700. REVIVE640, REVIVE630, REVIVE707 and REVIVE637) are digital wireless air conduction hearing aids all using the WidexLink radio. The different series represent different price points for the CLEAR hearing aids (see discussion of difference in application). The WidexLink is a low power proprietary radio, which enables communication between hearing aids and from other peripheral units. We have two units which can communicate with the CLEAR hearing aids: a simple remote control (RC-DEX) which can change volume and program in the hearing aid and a programming unit (TM-DEX) which is used in combination with a universal programming interface nEARcom/NoahLink programming system. A detailed description of the WidexLink platform is available in the 510K application (K101699).

The added feature to the approved CLEAR440 hearing aid is the optional inter-ear Zen (IE-Zen) feature. Wireless is used in the IE-Zen to identify if the Zen program is used in a monaural mode or binaural mode. The IE-Zen is a tool that generates and delivers a relaxing sound background. It may also be used as a sound source to distract and/or mask tinnitus in tinnitus sufferers. A broadband noise and 5 melodic tone patterns that are generated using fractal mathematics can be selected as Zen programs. The clinician can adjust the characteristics (intensity, pitch and tempo) of each program and the patient can retrieve up to 3 programs with the touch of a program button. The IE-Zen can be used with or without amplification.

AI/ML Overview

Here's an analysis of the acceptance criteria and supporting study for the Widex IE-Zen Program, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state formal, quantitative acceptance criteria for the IE-Zen program. Instead, it relies on comparative equivalence to a predicate device and positive user feedback. However, we can infer some implied criteria and list the corresponding performance as reported.

Acceptance Criteria (Inferred)	Reported Device Performance
Safety: No additional risks compared to conventional hearing aids and/or tinnitus maskers.	"There is no more risk to the use of the IE-Zen program than the use of conventional hearing aids and/or tinnitus masker." "There is also no known risk associated with the use of wireless hearing aids (WidexLink) because of its low output level and magnetic field strengths (K101699)."
Acoustic Similarity: Overall sound levels of IE-Zen tones are similar to predicate Zen tones.	"Acoustic measurements of the IE-Zen tones showed that the overall levels of the IE-Zen and Zen tones were similar."
Acceptability/Relaxation: A majority of listeners find the IE-Zen tones "somewhat relaxing" or "very relaxing."	"A study on the acceptability of the IE-Zen tones to hearing impaired people showed that the majority of listeners (80%) rated the IE-Zen tones as 'somewhat relaxing' or 'very relaxing.'"
Preference: IE-Zen tones are preferred similarly to predicate Zen tones. (Implied by the acceptability study)	"The preference for the IE-Zen tones was similar to that for the Zen tones."
Effectiveness (Implied): Expected to be as effective as the predicate device (Zen program) in reducing tinnitus severity. (Supported by predicate device's efficacy)	An independent study at UCSF "demonstrated that the Zen tones were effective in reducing tinnitus severity for some tinnitus sufferers. The IE-Zen program is expected to be just as effective as the predicate device (K080955) while the safety of the hearing aid is unaltered."

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: The text states, "A study on the acceptability of the IE-Zen tones to hearing impaired people showed that the majority of listeners (80%)." While it refers to "hearing impaired people" and "listeners," a specific numerical sample size (e.g., N=X) for this acceptability study is not provided.
Data Provenance: The document does not explicitly state the country of origin for the acceptability study. It mentions an "independent study conducted at UCSF" for the predicate Zen tones' effectiveness in reducing tinnitus severity, implying the U.S. for that specific study. The nature (retrospective or prospective) of the acceptability study is not specified.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This information is not provided in the document. The acceptability study relies on subjective listener ratings, not expert-established ground truth in the traditional sense of medical image or diagnosis evaluation. The "ground truth" here is the individual's subjective experience of "relaxing."

4. Adjudication Method for the Test Set

This information is not applicable/provided. Since the "ground truth" is individual listener perception of "relaxing," there is no mention of an adjudication process among experts.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted as described for human readers improving with AI vs. without AI assistance. This device is not an AI diagnostic tool and doesn't involve human readers interpreting AI output. The study focused on the acceptability and preference of the IE-Zen tones by individuals.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Yes, in essence. The acceptability study evaluates the performance of the IE-Zen program itself (the algorithm generating the tones) as perceived by listeners, without explicitly involving real-time human intervention in the tone generation or modification during the test. The device generates the sounds, and the user experiences them.

7. Type of Ground Truth Used

Subjective User Feedback/Self-Reported Experience: For the acceptability study, the "ground truth" was the subjective rating by hearing-impaired individuals themselves as to whether the tones were "somewhat relaxing" or "very relaxing."
Clinical Efficacy (for predicate device, inferred for IE-Zen): For the predicate Zen tones, the ground truth for effectiveness was reduction in tinnitus severity, presumably measured through patient self-report questionnaires or clinical assessments (though the exact method from the UCSF study is not detailed here).

8. Sample Size for the Training Set

This information is not provided and is likely not relevant as the IE-Zen program is described as generating tones based on fractal mathematics and clinician adjustments, rather than being a deep learning model trained on a large dataset. No training set is mentioned for the development of the tone-generation logic itself.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As the text does not describe an AI training process with a specific training set or ground truth in the context of machine learning, this question does not apply to the information presented. The device's functionality is based on predefined algorithms and user-adjustable parameters.

Summary

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K110973

510(K) Summary for the Widex JE-Zen Program in the CLEAR Series Hearing MAY – 5 2011

Aids Aids

Submission Date	April 4, 2011
Applicant	Widex USA35-53, 24th streetLong Island City, NY 11106Phone: 800-221-0188
Contact Person	Francis Kuk, Ph.D.2300 Cabot Drive, Suite 415Lisle, IL 60532630-245-0025Email: Fkuk@widexusa.com Fkuk@aol.com
Trade or Proprietary Name	IE-Zen (in CLEAR series hearing aid)
Device Common Name/Classification name	Tinnitus Masker
Product Code	KLW
Classification of Device	Class II for wireless hearing aidsClass II for tinnitus masker
Establishment Registration Number	2430101
Address of Manufacturing Site	Widex A/SNymoellevej 6DK-3540 LyngeDenmark
Reason for Submission	Inclusion of IE-Zen in CLEAR serieshearing aids
Marketed Devices withSubstantial Equivalence	K101699 for WidexLink in CLEAR440K080955 Zen program in Widex mind440

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510 K Executive Summary

Description of Device

Indications for use

The IE-Zen program is intended to provide a relaxing sound background for adults (21 years and older) who desire to listen to such a background in quiet. It may be used as a sound therapy tool in a tinnitus treatment program that is programmed by a licensed hearing healthcare professional (audiologists, hearing aid specialists, otolaryngologists) who is trained in tinnitus management.

Technological comparison to predicate devices

The WidexLink wireless platform used in the CLEAR440 is identical to the WidexLink platform used in the CLEAR440, of which a 510K has been granted (K101699).

The IE-Zen is substantially equivalent to the original Zen program (K080955) in rationale, mechanism, and applications. Whereas the original Zen program generates the full set of tones regardless of how the mind440 is worn (either binaurally or monaurally), the IE-Zen in the CLEAR only generates a half set of tones in each CLEAR hearing aid

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of a binaural pair, and the full-set of tones if the CLEAR is worn monaurally. This is possible in the CLEAR because of inter-ear wireless communication between hearing aids. When a partner hearing aid (belonging to the CLEAR family) is detected, the IE-Zen program registers binaural hearing aid use and sets the IE-Zen in each CLEAR hearing aid to half the total tones generated.

Risks to health

There is no more risk to the use of the IE-Zen program than the use of conventional hearing aids and/or tinnitus masker. There is also no known risk associated with the use of wireless hearing aids (WidexLink) because of its low output level and magnetic field strengths (K101699). Appropriate labeling is included to ensure proper use of the device.

Conclusion from preclinical tests and clinical studies

Acoustic measurements of the IE-Zen tones showed that the overall levels of the IE-Zen and Zen tones were similar. As expected, the spectra of the IE-Zen tones were different from the Zen tones between binaural and monaural presentations. A study on the acceptability of the IE-Zen tones to hearing impaired people showed that the majority of listeners (80%) rated the IE-Zen tones as "somewhat relaxing" or ""very relaxing." The preference for the IE-Zen tones was similar to that for the Zen tones. An independent study conducted at UCSF demonstrated that the Zen tones were effective in reducing tinnitus severity for some tinnitus sufferers. The IE-Zen program is expected to be just as effective as the predicate device (K080955) while the safety of the hearing aid is unaltered.

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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a stylized eagle with three lines forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" are arranged in a circular fashion around the eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

MAY - 5 2011

Widex USA C/O Francis Kuk, Ph.D. 2300 Cabot Drive, Suite 415 Lisle, IL 60532

Re: K110973

Trade/Device Name: IE-Zen Regulation Number: 21 CFR 874.3400 Regulation Name: Tinnitus masker Regulatory Class: Class II Product Code: KLW Dated: April 4, 2011 Received: April 6, 2011

Dear Dr. Kuk:

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.

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Page 2 - Dr. Francis Kuk

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 (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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Signature

Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K110973

Indications for Use

510(k) Number (if known): K110973

Device Name: IE-Zen program (in CLEAR series hearing aids including CLEAR Super)

Indications for Use:

Intended Use

The IE-Zen program is intended to be used in quiet where hearing everyday sounds is not critical.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Shullen King

(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices

KI10973 510(k) Number.

Regulation Number and Section

§ 874.3400 Tinnitus masker.

(a)
Identification. A tinnitus masker is an electronic device intended to generate noise of sufficient intensity and bandwidth to mask ringing in the ears or internal head noises. Because the device is able to mask internal noises, it is also used as an aid in hearing external noises and speech.(b)
Classification. Class II. The special control for this device is patient labeling regarding:(1) Hearing health care professional diagnosis, fitting of the device, and followup care,
(2) Risks,
(3) Benefits,
(4) Warnings for safe use, and
(5) Specifications.