(85 days)
No
The description focuses on generating sounds using fractal mathematics and adjustable parameters, with no mention of AI or ML algorithms for sound generation, adaptation, or analysis.
Yes
The device is intended to be used as a "sound therapy tool in a tinnitus treatment program" and "used as a sound source to distract and/or mask tinnitus in tinnitus sufferers," which are therapeutic applications.
No
The device is described as a sound therapy tool intended to provide a relaxing sound background and distract/mask tinnitus. It does not perform any diagnostic function.
No
The device is described as an "optional listening program within the Widex Mind 440 digital hearing aid family," indicating it is integrated into a hardware device (hearing aid) and not a standalone software application.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections.
- Device Function: The Zen program is a sound therapy tool that generates and delivers sound to the ear. It does not involve the analysis of any biological samples from the patient.
- Intended Use: The intended use is to provide a relaxing sound background and potentially distract/mask tinnitus. This is a therapeutic or management function, not a diagnostic one.
The device operates externally and interacts with the patient's auditory system, not with internal biological samples for diagnostic purposes.
N/A
Intended Use / Indications for Use
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.
Product codes
ESD, KLW
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.
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
Adults (21 years and older)
Intended User / Care Setting
licensed hearing healthcare professional (audiologists, hearing aid specialists, otolaryngologists) who is trained in tinnitus management.
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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K043274 Neuronomics Tinnitus Treatment, K011366 Siemens Custom TCI-Combi, K974501 Digital tinnitus masking system
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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 Company |
| 35-53, 24th street | |
| Long Island City, NY 11106 | |
| Phone: 800-221-0188 | |
| Contact Person | Francis Kuk, Ph.D. |
| 2300 Cabot Drive, Suite 415 | |
| Lisle, IL 60532 | |
| 630-245-0025 | |
| Email: 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 aid |
| Class II for tinnitus masker | |
| Establishment Registration Number | 2430101 |
| Address of Manufacturing Site | Widex A/S |
| Ny Vestergaardsvej 25 | |
| DK-3500 Vaerloese | |
| Denmark | |
| Reason for Submission | New Product |
| Marketed Devices with | |
| Substantial Equivalence | K043274 Neuronomics Tinnitus Treatment |
| K011366 Siemens Custom TCI-Combi | |
| K974501 Digital tinnitus masking system |
:
510(K) Summary for the Widex Zen Program in the Mind 440 Hearing Aid
1
Indications for use
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.
Description of Device
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.
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.
2
| 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 relaxed | ||
| listening background; may be used in connection | ||
| with Tinnitus Management programs | A tool for delivery and monitoring audio stimuli | |
| (broadband noise and music) required for | ||
| Neuramonics tinnitus treatment | ||
| Zen alone is intended for use in quiet or during | ||
| leisure activities; HA+ Zen or HA alone can be | ||
| used at any time depending on the wearer's needs | Intended for use in quiet or during leisure | |
| activities | ||
| Indications For | ||
| Use | Hearing impaired wearers desiring a relaxed | |
| listening background; also patients reporting of | ||
| tinnitus, 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 with | |
| Zen, or Zen alone depending on clinician's | ||
| recommendations and wearer's needs | Only worn for tinnitus rehabilitation on an intended | |
| schedule of decreasing use over time | ||
| Where Used | May be used anywhere | Intended for in-home use |
| Physical | ||
| Descriptions | Within the Mind 440 hearing aid family; takes the | |
| form 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 tinnitus | |
| through masking and distraction | ||
| a. digital synthesis of sounds (music and noise) | ||
| using fractal mathematics | a. pre-recorded relaxing music stored within a memory | |
| card | ||
| Mechanism | b. 4 default melodic tone patterns plus one | |
| broadband noise | b. 4 music passages - two classic, two new age plus a | |
| broadband "neural shower" noise | ||
| c. music does not repeat itself, noise is random | c. music repeats itself | |
| d. generated sounds spectrally shaped by the | ||
| hearing loss of wearer | d. music and noise spectrally shaped by hearing loss | |
| of wearer | ||
| e. pitch, tempo and intensity can be adjusted by | ||
| clinician | e. music stimuli cannot be changed | |
| f. wearer adjusts separate VC to change level of | ||
| hearing aid and Zen sounds | f. wearer adjusts VC to change level of music | |
| g. level of music and noise typically set at 5 dB | ||
| above patient's in-situ threshold | g. level of music is set to "low" | |
| h. music provides a relaxing listening background | ||
| to distract and partially mask tinnitus | h. music provides a relaxing background for | |
| distraction of tinnitus | ||
| i. a broadband white noise is available for | ||
| immediate masking | i. a broad band noise ("neural shower") for immediate | |
| masking of tinnitus | ||
| Maximum Output | ||
| Characteristics | Maximum output depends on hearing aid style and | |
| hearing loss of patient, amplified sounds typically | ||
| set below LDL of patient; Zen program level is also | ||
| internally monitored | Maximum output fixed at 80 dB SPL | |
| Output frequency response limited by receiver | ||
| used, the upper limit is typically between 6500 Hz | ||
| and 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 10 | |
| zinc air depending on model) | Uses rechargeable lithium polymer battery | |
| Dispensing | ||
| Professionals | Clinicians who are trained in tinnitus management | |
| (when Zen is used for tinnitus relief) | Clinicians who are trained in tinnitus management and | |
| Neuromanics device | ||
| Associated | ||
| Training Course | Training on the fitting of the Mind 440 hearing aid | |
| is provided; Clinician should be trained on tinnitus | ||
| management to use Zen for tinnitus relief | Specific training course for clinicians | |
| Quality Assurance | ||
| Standard | ANSI 3.21-2003 to ensure proper functioning of HA | IEC 60601-1 and 60601-1-2 to meet medical safety |
| standards | ||
| Siemens TCI-Combi | Digital Tinnitus Masking System | |
| Intended Use | A tool for generating and delivery of broadband | |
| noise to be used in connection with Tinnitus | ||
| Management programs | A collection of 4 CDs for delivery of audio stimuli for | |
| temporary relief of tinnitus | ||
| Intended for use as hearing aid alone, masker | ||
| alone or masker+HA in quiet or during leisure | ||
| activities | Intended to be used in quiet or during leisure activities | |
| Indications For | ||
| Use | Tinnitus patients with a hearing loss, i.e., hearing | |
| aid 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's | ||
| recommendations and wearer's needs | May be used any time for tinnitus relief, no specific | |
| schedule | ||
| Where Used | May be used anywhere | Intended for in-home use |
| Physical | ||
| Descriptions | Takes the form of any custom HA (i.e., ITE or ITC) | Any commercial CD player and headphone/ |
| loudspeaker; may be outputted through hearing aids | ||
| via direct audio input (DAI) | ||
| Use broadband noises to manage tinnitus through | ||
| masking and distraction | Use masking noises and computer generated music to | |
| manage tinnitus through masking and relaxation | ||
| a. digitally generated noises | a. digitally recorded sounds | |
| Mechanism | b. broadband noise between 84 and 89 dB SPL (in | |
| masker alone mode) | b. broadband signals - masking noise, music, nature | |
| sounds, "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, speech | ||
| and high-frequency | e. music and noise stimuli cannot be changed | |
| f. wearer adjusts VC to change level of HA and | ||
| masker | f. wearer adjusts VC of CD player to change level of | |
| music or stimuli | ||
| g. level of noise is set by clinician with patient to | ||
| just mask the tinnitus | g. level of sound is adjusted by wearer | |
| h. no music is available | h. alpha rhythm music and nature sounds provide a | |
| relaxing listening background during tinnitus masking | ||
| i. broadband noise is used for immediate and | ||
| temporary masking of tinnitus | i. a broadband and frequency specific noises are | |
| available for immediate masking | ||
| Maximum Output | ||
| Characteristics | Maximum output of noise is lower than 89 dB SPL | |
| (in masker only), MPO on hearing aid is adjusted | ||
| by clinician based on patient's discomfort level | Maximum output not controlled by software but by | |
| patients | ||
| Output frequency response limited to below 7000 | ||
| Hz | Output frequency response dependent on headphone | |
| and loudspeaker used by the patient | ||
| Power Source | Uses any hearing aid battery ( #312 or #10 Zinc Air | |
| depending on model) | Power supply dependent on the power source of the | |
| CD player - line to battery supply | ||
| Dispensing | ||
| Professionals | Clinicians who are trained in tinnitus management | Not specified, commercially available |
| Associated | ||
| Training Course | No specific clinical program is required; to be used | |
| as a tool in tinnitus management | No specific clinical program is required; to be used as | |
| a tool in tinnitus management | ||
| Quality Assurance | ||
| Standard | ANSI 3.21-2003 to ensure proper functioning of HA | Not applicable |
.
3
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.
4
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.
5
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.
6
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
7
Indications for Use
510(k) Number (if known): K080955___
Device Name: Zen program (Mind 440 hearing aid)_
Indications for Use:
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.
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)