The 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 prescribed by a licensed hearing healthcare professional (audiologists, hearing aid specialists, otolaryngologists) who is trained in tinnitus management.

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

Device Description

The Zen program is an optional listening program within the Widex Mind 440 digital hearing aid family. It 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 as many as 4 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 Zen can be used with or without amplification.

AI/ML Overview

The Widex Zen program, an optional listening program within the Mind 440 digital hearing aid family, generates and delivers a relaxing sound background. It can also be used as a sound source to distract and/or mask tinnitus in tinnitus sufferers.

Here's an analysis of the acceptance criteria and the study that supports it:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Effectiveness for Relaxing Sound Background:	"the majority of listeners (85%) rated the Zen tones as ‘somewhat relaxing' or ‘very relaxing.'"
Effectiveness for Tinnitus Management:	Expected to be "just as effective as the predicate devices" (K043274 Neuromonics Tinnitus Treatment, K011366 Siemens Custom TCI-Combi, K974501 Digital tinnitus masking system).
Safety:	"no more risk to the use of the Zen program than the use of conventional hearing aids and/or tinnitus masker." The safety of the hearing aid is "unaltered."

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

Sample Size: "A study on the acceptability of the Zen tones to hearing impaired people showed that the majority of listeners (85%) rated the Zen tones as 'somewhat relaxing' or 'very relaxing.'" The exact numerical sample size for this acceptability study is not provided.
Data Provenance: Not explicitly stated, but given the manufacturer (Widex A/S, Denmark) and the contact person's location in the US (Illinois), it could be either a European or US study. The document does not specify if the study was retrospective or prospective.

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

For the acceptability study, the "ground truth" was based on subjective ratings ("somewhat relaxing" or "very relaxing") from hearing-impaired individuals. There is no mention of experts establishing ground truth for this particular finding.
For the tinnitus management aspect, the claim of effectiveness is based on substantial equivalence to predicate devices, rather than a new study with expert-established ground truth.

4. Adjudication Method for the Test Set

Not applicable as the reported data for the acceptability study relies on individual participant ratings, not expert adjudication of a test set. For the tinnitus management claim, it's based on equivalence to predicate devices, not a separate adjudication process.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

No MRMC comparative effectiveness study was mentioned or performed. The device is a sound-generating program within a hearing aid, not an AI diagnostic tool that assists human readers with interpretations. Therefore, the concept of "human readers improve with AI vs without AI" is not applicable here.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, for the "acceptability of the Zen tones," the performance was evaluated based on direct feedback from users, which can be considered standalone performance in terms of the device's ability to generate tones rated as relaxing.
For the tinnitus management claim, the "standalone" performance is inferred through substantial equivalence to other devices that operate without continuous human intervention during their primary function (sound generation/masking).

7. The Type of Ground Truth Used

For the reported acceptability data: Subjective user experience/perception ("somewhat relaxing" or "very relaxing") served as the ground truth.
For the tinnitus management claim: Equivalence to the demonstrated effectiveness of predicate devices that serve similar functions. There is no new "ground truth" established for tinnitus relief in this specific submission.

8. The Sample Size for the Training Set

Not applicable / not provided. The Zen program is described as generating "fractal mathematics" patterns and broadband noise. This implies a rule-based or algorithmically generated system rather than a machine learning model that requires a training set.

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

Not applicable. As the device's sound generation mechanism is likely based on mathematical algorithms and digital synthesis rather than machine learning, there would be no "training set" or corresponding ground truth establishment in the conventional sense of AI/ML development. The design principles for the "relaxing sound background" would be based on audiological and psychoacoustic research.

Summary

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Image /page/0/Picture/0 description: The image shows the text "ROSOFSS JUN 27 2008". The text appears to be a stamp or handwritten note. The date is June 27, 2008.

Submission Date	3/ 31/ 2008/: 5/12/ 2008; 6/17/2008
Applicant	Widex Hearing Aid Company35-53, 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@widexmail.com Fkuk@aol.com
Trade or Proprietary Name	Zen program (Mind 440 hearing aid)
Device Common Name/Classification name	Hearing Aid, Tinnitus Masker
Product Code	ESD, KLW
Classification of Device	Class I for hearing aidClass II for tinnitus masker
Establishment Registration Number	2430101
Address of Manufacturing Site	Widex A/SNy Vestergaardsvej 25DK-3500 VaerloeseDenmark
Reason for Submission	New Product
Marketed Devices withSubstantial Equivalence	K043274 Neuronomics Tinnitus TreatmentK011366 Siemens Custom TCI-CombiK974501 Digital tinnitus masking system

510(K) Summary for the Widex Zen Program in the Mind 440 Hearing Aid

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Indications for use

Description of Device

Technological comparison to predicate devices

The Zen program digitally generates a broadband noise and melodic tones as a tool to manage tinnitus. This is similar to the principles and tools/stimuli used by these predicate devices - K001366; K043274, K974501. The difference is that the Neuromonics device (K043274) uses pre-recorded music and the Siemens TCI-Combi device (K001366) uses only a broadband noise (i.e., no music) stimulus. The DTMS (K974501) device provides a collection of tinnitus masking sounds which also included computer generated musical tones similar to those generated in the Zen program. Furthermore, the Neuromonics is also a dedicated device (for tinnitus), the Siemens TCI-Combi is a hearing aid plus tinnitus masker, and the DTMS is a 4-CD collection that can be played on any CD player. Hearing aid wearers may reproduce the DTMS sounds on any hearing aids through the use of direct audio input (DAI). In that regard, the treatment of the DTMS sounds is similar to how the Zen sounds are treated in the Mind 440 hearing aid.

A side by side comparison among the Zen and the Neuromonics, the Siemens TCI-Combi, and the DTMS predicate devices is shown in the Table below. This comparison shows that the Zen program has similar effectiveness as the predicate devices.

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	Zen in Mind 440 Hearing Aid	Neuromonics Tinnitus Treatment System
Intended Use	A tool for generating and delivery of sound stimuli(broadband noise and musical tones) for a relaxedlistening background; may be used in connectionwith Tinnitus Management programs	A tool for delivery and monitoring audio stimuli(broadband noise and music) required forNeuramonics tinnitus treatment
	Zen alone is intended for use in quiet or duringleisure activities; HA+ Zen or HA alone can beused at any time depending on the wearer's needs	Intended for use in quiet or during leisureactivities
Indications ForUse	Hearing impaired wearers desiring a relaxedlistening background; also patients reporting oftinnitus, i.e., hearing aid and tinnitus device	Tinnitus patients with or without a hearing loss, i.e.,dedicated tinnitus device
Target Population	Adults (21 yr and older) with tinnitus	Adults with tinnitus
Schedule of Use	May be used as hearing aid alone, hearing aid withZen, or Zen alone depending on clinician'srecommendations and wearer's needs	Only worn for tinnitus rehabilitation on an intendedschedule of decreasing use over time
Where Used	May be used anywhere	Intended for in-home use
PhysicalDescriptions	Within the Mind 440 hearing aid family; takes theform of any hearing aid style, e.g. BTE, ITE, ITC,CIC etc	iPod-like device (4.06" x 2.32" x 0.71") with pre-recorded music delivered through Bose headphones
	Uses broadband noise and melodic tones.Manages tinnitus through masking and distraction	Uses broadband noise and music to manage tinnitusthrough masking and distraction
	a. digital synthesis of sounds (music and noise)using fractal mathematics	a. pre-recorded relaxing music stored within a memorycard
Mechanism	b. 4 default melodic tone patterns plus onebroadband noise	b. 4 music passages - two classic, two new age plus abroadband "neural shower" noise
	c. music does not repeat itself, noise is random	c. music repeats itself
	d. generated sounds spectrally shaped by thehearing loss of wearer	d. music and noise spectrally shaped by hearing lossof wearer
	e. pitch, tempo and intensity can be adjusted byclinician	e. music stimuli cannot be changed
	f. wearer adjusts separate VC to change level ofhearing aid and Zen sounds	f. wearer adjusts VC to change level of music
	g. level of music and noise typically set at 5 dBabove patient's in-situ threshold	g. level of music is set to "low"
	h. music provides a relaxing listening backgroundto distract and partially mask tinnitus	h. music provides a relaxing background fordistraction of tinnitus
	i. a broadband white noise is available forimmediate masking	i. a broad band noise ("neural shower") for immediatemasking of tinnitus
Maximum OutputCharacteristics	Maximum output depends on hearing aid style andhearing loss of patient, amplified sounds typicallyset below LDL of patient; Zen program level is alsointernally monitored	Maximum output fixed at 80 dB SPL
	Output frequency response limited by receiverused, the upper limit is typically between 6500 Hzand 10 KHz depending on hearing aid style	Output frequency response to 12.5 K Hz
Power Source	Uses any 1.4 V hearing aid battery (#13, 312 or 10zinc air depending on model)	Uses rechargeable lithium polymer battery
DispensingProfessionals	Clinicians who are trained in tinnitus management(when Zen is used for tinnitus relief)	Clinicians who are trained in tinnitus management andNeuromanics device
AssociatedTraining Course	Training on the fitting of the Mind 440 hearing aidis provided; Clinician should be trained on tinnitusmanagement to use Zen for tinnitus relief	Specific training course for clinicians
Quality AssuranceStandard	ANSI 3.21-2003 to ensure proper functioning of HA	IEC 60601-1 and 60601-1-2 to meet medical safetystandards


	Siemens TCI-Combi	Digital Tinnitus Masking System
Intended Use	A tool for generating and delivery of broadbandnoise to be used in connection with TinnitusManagement programs	A collection of 4 CDs for delivery of audio stimuli fortemporary relief of tinnitus
	Intended for use as hearing aid alone, maskeralone or masker+HA in quiet or during leisureactivities	Intended to be used in quiet or during leisure activities
Indications ForUse	Tinnitus patients with a hearing loss, i.e., hearingaid and tinnitus device	Tinnitus patients with or without a hearing loss
Target Population	Adults or children over 5 years of age with tinnitus	Adults with tinnitus
Schedule of Use	May be worn as hearing aid alone, masker alone,or HA plus masker depending on clinician'srecommendations and wearer's needs	May be used any time for tinnitus relief, no specificschedule
Where Used	May be used anywhere	Intended for in-home use
PhysicalDescriptions	Takes the form of any custom HA (i.e., ITE or ITC)	Any commercial CD player and headphone/loudspeaker; may be outputted through hearing aidsvia direct audio input (DAI)
	Use broadband noises to manage tinnitus throughmasking and distraction	Use masking noises and computer generated music tomanage tinnitus through masking and relaxation
	a. digitally generated noises	a. digitally recorded sounds
Mechanism	b. broadband noise between 84 and 89 dB SPL (inmasker alone mode)	b. broadband signals - masking noise, music, naturesounds, "alpha rhythm" music at various SPL
	c. random noise	c. finite duration of sample, may repeat
	d. noise is not shaped by hearing loss of wearer	d. stimuli are not shaped by hearing loss of wearer
	e. choice of 4 different noises - white, pink, speechand high-frequency	e. music and noise stimuli cannot be changed
	f. wearer adjusts VC to change level of HA andmasker	f. wearer adjusts VC of CD player to change level ofmusic or stimuli
	g. level of noise is set by clinician with patient tojust mask the tinnitus	g. level of sound is adjusted by wearer
	h. no music is available	h. alpha rhythm music and nature sounds provide arelaxing listening background during tinnitus masking
	i. broadband noise is used for immediate andtemporary masking of tinnitus	i. a broadband and frequency specific noises areavailable for immediate masking
Maximum OutputCharacteristics	Maximum output of noise is lower than 89 dB SPL(in masker only), MPO on hearing aid is adjustedby clinician based on patient's discomfort level	Maximum output not controlled by software but bypatients
	Output frequency response limited to below 7000Hz	Output frequency response dependent on headphoneand loudspeaker used by the patient
Power Source	Uses any hearing aid battery ( #312 or #10 Zinc Airdepending on model)	Power supply dependent on the power source of theCD player - line to battery supply
DispensingProfessionals	Clinicians who are trained in tinnitus management	Not specified, commercially available
AssociatedTraining Course	No specific clinical program is required; to be usedas a tool in tinnitus management	No specific clinical program is required; to be used asa tool in tinnitus management
Quality AssuranceStandard	ANSI 3.21-2003 to ensure proper functioning of HA	Not applicable

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Conclusion from preclinical tests and clinical studies

A study on the acceptability of the Zen tones to hearing impaired people showed that the majority of listeners (85%) rated the Zen tones as "somewhat relaxing" or ""very relaxing." No preclinical and clinical testing was conducted on the Zen program re: tinnitus because similar effectiveness has been demonstrated by the predicate devices. The Zen program is expected to be just as effective as the predicate devices while the safety of the hearing aid is unaltered.

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Information required under Title 21, Section 874.3400, and not already provided above

Risks to health

There is no more risk to the use of the Zen program than the use of conventional hearing aids and/or tinnitus masker. Appropriate labeling will also be included to ensure proper use of the program.

Hearing Healthcare Professional Diagnosis

The sale and fitting of the Zen program in the mind440 will only be conducted through a Hearing Healthcare Professional, such as an audiologist, hearing aid specialist, or otolaryngologist.

Benefits

The Zen program provides a relaxing listening background for some people. When the Zen program is used in a tinnitus management program, its wearer may experience some relief from tinnitus.

Warnings for safe use

Use of the Zen program may interfere with hearing everyday sounds including speech. It should not be used when hearing such sounds are important. Switch the hearing aid to a non-Zen program in those situations.

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Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wing. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Widex Hearing Aid Company c/o Dr. Francis Kuk Director of Audiology Suite 415 2300 Cabot Dr. Lisle, IL 60532

Re: K080955

Trade/Device Name: Zen program Regulation Number: 21 CFR 874.3400 Regulation Name: Tinnitus masker Regulatory Class: Class II Product Code: KLW Dated: March 31, 2008 Received: April 3, 2008

Dear Dr. Kuk:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave rove 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 for use stated in the enorment date of the enactment date of the Medical Device Amendments, or to commerce prov to that have been reclassified in accordance with the provisions of the Federal Food, Drug, devices that have been require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The I ou may, morely misions of the Act include requirements for annual registration, listing of general voluent proficturing practice, labeling, and prohibitions against misbranding and adulteration.

JUN 2 7 2008

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device to such additional controls. Existing major regulations affecting your device can may or subject to back as a 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 1 toase of actived that I Drimination that your device complies with other requirements of the Act that I Drimas intact a and regulations administered by other Federal agencies. You must or any I oderal babates as requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CI N I at 607), adoling (21 CFR 220 and if applicable, and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Francis Kuk, Ph.D. CCC-A

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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,

Malvina B. Egleston, und

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

Enclosure

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Indications for Use

510(k) Number (if known): K080955___

Device Name: Zen program (Mind 440 hearing aid)_

Indications for Use:

Intended Use

The 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)

Shulhen Peng

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

510(k) Number

Page 1 of 1

× Prescription Use (Per 21 CFR 801.109)

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.