(114 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and there is no other language in the summary that suggests the use of AI or ML. The device description focuses on embedding sounds and spectral content into music, which is a signal processing technique, not necessarily AI/ML.
Yes
The device is described as providing "temporary relief of tinnitus symptoms" and is used as part of a "tinnitus management program," directly addressing a health condition.
No
The device is described as a treatment for tinnitus symptoms, not a diagnostic device. It's a software application designed to embed sounds into music for relief, and its components include software for "tinnitus pitch match and audiogram submission" for healthcare professionals, which is used for data input relevant to treatment, not for diagnosing a condition itself.
Yes
The device is described as a "software application" that embeds sounds into music for tinnitus relief. While it produces music files for patient use, the core device functionality and description focus solely on the software component. There is no mention of accompanying hardware that is part of the regulated device itself.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information about a person's health. They are used to diagnose, monitor, or screen for diseases or conditions.
- Device Function: The Sound Options Tinnitus Treatment device is a software application that generates personalized music therapy to relieve tinnitus symptoms. It does not analyze any biological specimens from the patient.
- Intended Use: The intended use is for the temporary relief of tinnitus symptoms by providing sound therapy, not for diagnosing or monitoring a medical condition through the analysis of biological samples.
- Device Description: The description focuses on the software's ability to embed sounds and spectral content into music, not on any analytical capabilities related to biological samples.
Therefore, the device's function and intended use clearly fall outside the scope of an In Vitro Diagnostic device. It is a therapeutic device that provides sound therapy.
N/A
Intended Use / Indications for Use
The device, Sound Options Tinnitus Treatment, version SO 2.0, is for the temporary relief of tinnitus symptoms. The device is a software application that embeds sounds and spectral content into music to relieve patients suffering from tinnitus and can be used as part of a tinnitus management program for adults 18 years and older. The device is for prescription use by a physician, audiologist or other healthcare professional.
Product codes (comma separated list FDA assigned to the subject device)
KLW
Device Description
The device is a software application that embeds sounds and spectral content into music to relieve patients suffering from tinnitus and can be used as part of a tinnitus management program.
The Sound Options device software version is 2.0. The device comprises of tinnitus pitch match and audiogram submission software for health care professionals (Web Software) and Sound Options software application for sound therapy generation (manufacturer use only)
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 18 years and older
Intended User / Care Setting
For prescription use by a physician, audiologist or other healthcare professional.
Patient assessment is done at the clinic by a qualified health care professional. Software programming is done at the manufacturer's office. Sound therapy music files produced may be listened to / used by patients at home or anywhere.
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)
Clinical Study:
Objective: To determine how effective Sound Options customized music is at reducing or eliminating tinnitus symptoms over the span of several months to a year.
Location of Study: Canada
Level of Evidence: Randomized, multi-arm, "blinded" study with concurrent sham (placebo) control
Description of Subjects:
Inclusion Criteria: Presence of mono- or bilateral tinnitus ≥12 months; Agree to ≥2 hrs of daily music listening over 12 months; ≥18 years old; English language abilities to answer questionnaires; Tinnitus Handicap Inventory (THI) score (calculated after phone interview) > 26.
Exclusion Criteria: History of neurological/psychiatric disorders; Medical illness that affects tinnitus therapy, severe hyperacusis, conductive or retrocochlear hearing loss, or Meniere's Disease; Taking ototoxic medication during the study; Constant exposure to loud noise; THI score 70dB HL for frequencies
§ 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.
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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 28, 2016
Sound Options Tinnitus Treatments, Inc. Ms. Navneet Sekhon President AxSource Consulting, Inc. 336 Bronte Street South, Suite 224-225 Milton, Ontario L9T 7W6 CA
Re: K161562
Trade/Device Name: Sound Options Tinnitus Treatment Regulation Number: 21 CFR 874.3400 Regulation Name: Tinnitus Masker Regulatory Class: Class II Product Code: KLW Dated: August 24, 2016 Received: August 25, 2016
Dear Ms. Sekhon:
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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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 and Part 809); 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 and Part 809), 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,
Eric A. Mann -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
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Indications for Use
510(k) Number (if known) K161562
Device Name
Sound Options Tinnitus Treatment
Indications for Use (Describe)
The device, Sound Options Timitus Treatment, version SO 2.0, is for the temporary relief of tinnitus symptoms. The device is a software application that embeds sounds and spectral content into music to relieve patients suffering from timitus and can be used as part of a timitus management program for adults 18 years and older. The device is for prescription use by a physician, audiologist or other healthcare professional.
Type of Use (Select one or both, as applicable)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ---------------------------------------------------------------------------------------------------------------------- | --------------------------------------------------------------------------------------------------------------------- |
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Image /page/3/Picture/0 description: The image is a logo for "Sound Options Tinnitus Treatments". The word "SOUND" is written vertically in blue letters, with a lightbulb replacing the "O". The word "OPTIONS" is written horizontally in blue letters, with the "O" in "OPTIONS" overlapping with the lightbulb. Above the word "OPTIONS" is the phrase "Tinnitus Treatments" in smaller letters.
SOUND OPTIONS 510(k) Number :K161562
7. 510(k) Summary - Submission No K161562
7.1 Owner Information
Name: Sound Options Tinnitus Treatments Inc. Device Trade name: Sound Options Tinnitus Treatment Device common name: Tinnitus Masker Address: 3841 Ridgepoint Way, Mississauga ON, L5N 7T7 Phone: 416-801-5356 Fax: N/A Contact: Michael Chrostowski President Title: michael@soundoptions.ca Email: Date of Preparation: 22 August 2016 510(k) Summary No: K161562
7.2 Regulatory Correspondent Information
| Name: | AxSource Consulting Inc. |
|---|---|
| Address: | 336 Bronte Street South, Suite 224-225 Milton, Ontario, L9T 7W6 |
| Office Phone: | 905-854-6059 |
| Cell: | 416-452-0100 |
| Contact Person: | Ms. Navneet Sekhon, President |
| Contact Person: | Rama Joshi, Regulatory Affairs Consultant |
| Email: | nav.sekhon@axsource.ca |
| Email: | rama@axsource.ca |
7.3 Device Information
| Trade Name | Sound Options Tinnitus Treatment |
|---|---|
| Common Name | Tinnitus masker |
| Classification name | Tinnitus Masker |
| Model Number | SO 2.0 |
| 510(k) Submitter / | |
| Holder - K161562 | Sound Options Tinnitus Treatments Inc. |
| Device Panel | Ear, Nose & Throat |
| Product Code | KLW |
| Classification | |
| Regulation | 874.3400 |
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Image /page/4/Picture/0 description: The image is a logo for "Sound Options Tinnitus Treatments". The word "Sound" is written vertically on the left side of the image. The word "Options" is written horizontally on the right side of the image. There is a lightbulb in place of the "O" in "Sound".
7.4 Indications for Use
The device, Sound Options Tinnitus Treatment, version SO 2.0, is for the temporary relief of tinnitus symptoms. The device is a software application that embeds sounds and spectral content into music to relieve patients suffering from tinnitus and can be used as part of a tinnitus management program for adults 18 years and older. The device is for prescription use by a physician, audiologist or other healthcare professional.
7.5 Predicate(s) / Substantially Equivalent Device(s)
| General
information | 510(k) | Predicate Device(s)
[510(k) summaries attached] |
|------------------------------|------------------------------------------------------|----------------------------------------------------|
| Trade Name | SoundCure™
Serenade™ Tinnitus
Treatment System | SoundCure Serenade Tinnitus
Treatment System |
| Model Number | unknown | unknown |
| 510(k) Submitter /
Holder | SoundCure Inc. | SoundCure Inc. |
| 510(k) Number | K111293 | K150065 |
| Device Panel | Ear, Nose & Throat | Ear, Nose & Throat |
| Product Code | KLW | KLW |
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Image /page/5/Picture/0 description: The image is a logo for "Sound Options Tinnitus Treatments". The word "SOUND" is written vertically in blue letters, with a lightbulb replacing the "O". The word "OPTIONS" is written horizontally in blue letters, with the lightbulb connecting the two words. Above the word "OPTIONS" are the words "Tinnitus Treatments" in a smaller font.
7.6 Device Description
The device is a software application that embeds sounds and spectral content into music to relieve patients suffering from tinnitus and can be used as part of a tinnitus management program.
The Sound Options device software version is 2.0. The device comprises of tinnitus pitch match and audiogram submission software for health care professionals (Web Software) and Sound Options software application for sound therapy generation (manufacturer use only)
Environment of Use
Patient assessment is done at the clinic by a qualified health care professional. Software programming is done at the manufacturer's office. Sound therapy music files produced may be listened to / used by patients at home or anywhere.
Principle of Operation
Patient hearing thresholds (from a standard audiometric assessment), tinnitus type (tonal, ringing or hissing) and pitch match are supplied by qualified health care professionals to Sound Options. Traceability is achieved via unique clinic and order identifiers. Using patient audiogram and tinnitus frequency / pitch match provided by health care professionals, the Sound Options software only device, SO 2.0, modifies frequency-specific amplitudes within music tracks to a customized music based sound therapy for tinnitus patients. OTS software is used to equalize the average volume of a collection of tracks (i.e. to make the average volume similar) prior to patient delivery. Customized music tracks are available to patients by download or on CD. Patients are to listen to the sound therapy at a comfortable volume level by adjusting the volume control on their personal music-playing device.
The Patient and Clinician User Manuals contain information on compatible MP3 players and headphones/earphones for use of the Sound Options sound therapy as well as how to set the volume to safe levels.
Safe levels were determined through bench testing for each of the recommended commercial device options described in the user manuals. Bench testing was conducted to ensure volume settings would not exceed 85 dBA.
7.7 Comparison of Technological Characteristics with Predicate Device(s)
Principles of operation and fundamental design and technology considerations are shared by Sound Options and its predicates.
Specifically, Sound Options and its predicate(s)
-
- Are non-invasive devices and so do not deliver energy to patients
-
- Do not pose any issues in terms of electrical, chemical, thermal or radiation safety
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Image /page/6/Picture/0 description: The image shows a logo for "Sound Options Tinnitus Treatments". The word "Sound" is written vertically on the left side of the image. There is a lightbulb in the middle of the word "Sound". The word "Options" is written horizontally on the right side of the image.
-
- Are non-sterile devices
-
- Stimuli can be amplitude modulated, placed in the background and ignored. Use broadband noise. Allow user volume control. (Principle of Operation)
-
- Broadband frequency sound is prescribed by qualified HCP and is custom to patient (Design)
-
- Include web software (Materials)
Sound Options is validated for system compatibility and performance.
The following technological differences exist between Sound Options and its predicates. However, the difference(s) raise no safety or effectiveness concerns for the Sound Options device in comparison to its predicates. Where possible, adequate control measures have been applied.
-
- Sound Options device, SO 2.0, differs from its predicates by utilizing the patient's personal music playing device while the predicate devices include a handheld device component with earphones. An OTS software used with SO 2.0 to equalize average sound volume has been validated in a clinical study as safe for sound volume management. Device labeling additionally instructs patients to adjust to a suitable sound volume using their personal music playing device.
-
- Sound Options device, SO 2.0, is a software only medical device while the predicates include hardware.
-
- Sound Options device, SO 2.0, is a software only medical device and involves no patient contacting material(s) while the predicates include patient contacting silicone earphones.
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Image /page/7/Picture/0 description: The image is a logo for "Sound Options Tinnitus Treatments". The word "Sound" is written vertically on the left side of the image, with a lightbulb replacing the "O" in "Sound". The word "Options" is written horizontally on the right side of the image. The words "Tinnitus Treatments" are written in smaller font above the word "Options".
SOUND OPTIONS 510(k) Number :K161562
7.8 Performance Data
7.8.1 Performance Testing
| SoundCureTM | SoundCureTM | Sound Options | Comparison to |
|---|---|---|---|
| SerenadeTM Tinnitus | |||
| Treatment System | |||
| K111293 | SerenadeTM Tinnitus | ||
| Treatment System | |||
| K150065 | Software device, | ||
| SO 2.0 | |||
| K161562 | Predicates | ||
| System Output | |||
| Performance | |||
| Testing, Hardware | |||
| Verification, | |||
| Software | |||
| Verification & | |||
| Validation, Battery | |||
| Useful Life In Vitro | |||
| Bench Testing. Max | |||
| Output fixed at | |||
| 92dB SPL, Output | |||
| Frequency | |||
| Response: 1-14 | |||
| kHz | System Output | ||
| Performance | |||
| Testing, Software | |||
| Verification & | |||
| Validation, Max | |||
| Output fixed at 92dB | |||
| SPL, Output | |||
| Frequency | |||
| Response: 1 - 14 | |||
| kHz | Sound Options has | ||
| a software only | |||
| device that has | |||
| been subjected to | |||
| Software | |||
| Verification and | |||
| Validation. | |||
| Output Frequency: | |||
| dependent on | |||
| patient headphones | |||
| (commercial) | Sound Options has a | ||
| software only device | |||
| that utilizes the patient's | |||
| personal music playing | |||
| device while the | |||
| predicate devices | |||
| include a handheld | |||
| device component with | |||
| earphones. Device | |||
| labeling instructs | |||
| patients to adjust to a | |||
| suitable sound volume | |||
| using their personal | |||
| music playing device. | |||
| This difference raises | |||
| no safety or | |||
| effectiveness concerns | |||
| for the Sound Options | |||
| device in comparison to | |||
| its predicates. |
7.8.2 Standards Conformance
The Sound Options device, SO 2.0, is a software only device of minor level of concern. In accordance with IEC 62304:2006 below, the device is deemed Class A: No injury or damage to health is possible. Sound Options has justified the minor level of concern for the software device.
In addition to the software device being of minor level of concern, partial device conformance to applicable sections of various FDA recognized standards and guidance documents have been used to support device safety and performance.
Sound Options software device, SO 2.0, complies with relevant sections of the following standards and FDA guidance documents through adequate risk management and maintenance processes, software verification and validation testing to user and functional requirement specifications and adequate labeling.
- . IEC 60601-1
- IEC 60601-1-11 Edition 2.0 2015-01 .
- IEC 62304:2006
- Guidance for the Content of Premarket Submissions for Software Contained in Medical ● Devices - Guidance for Industry and FDA Staff, May 2005
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Image /page/8/Picture/0 description: The image is a logo for "Sound Options Tinnitus Treatments". The logo is in blue and white. The word "Sound" is written vertically on the left side of the logo. There is a lightbulb in the middle of the word "Sound". The words "Tinnitus Treatments" are written in smaller font above the word "Options".
- General Principles of Software Validation; Final Guidance for Industry and FDA Staff, ● January 2002
- . Guidance for Industry, FDA Reviewers and Compliance on Off-The-Shelf Software Use in Medical Devices, September 9, 1999
The Sound Options software device and both predicate devices partially conform to the same standard IEC 60601-1.
7.8.3 Clinical Study
Objective
To determine how effective Sound Options customized music is at reducing or eliminating tinnitus symptoms over the span of several months to a year.
Location of Study
Canada
Level of Evidence
Randomized, multi-arm, "blinded" study with concurrent sham (placebo) control
Description of Subjects
| Inclusion Criteria | Exclusion Criteria |
|---|---|
| Presence of mono- or bilateral tinnitus ≥12 | |
| months | History of neurological/psychiatric disorders |
| Agree to ≥2 hrs of daily music listening over | |
| 12 months | Medical illness that affects tinnitus therapy, |
| severe hyperacusis, conductive or | |
| retrocochlear hearing loss, or Meniere's | |
| Disease | |
| ≥18 years old | Taking ototoxic medication during the study |
| English language abilities to answer | |
| questionnaires | Constant exposure to loud noise |
| Tinnitus Handicap Inventory (THI) score | |
| (calculated after phone interview) > 26 | THI score 70dB HL for |
| frequencies |