(28 days)
Not Found
No
The description mentions an "algorithm" and "firmware program code" for generating sounds and adjusting parameters, including an "audiogram shaping functionality" that can be "automatically adjusted". However, there is no mention of AI, ML, deep learning, training data, or any other terms typically associated with AI/ML technologies. The "automatically adjusted" feature appears to be based on a predefined algorithm or rule set related to the audiogram, not a learned model.
Yes
The device is intended to relieve patients suffering from tinnitus by generating sounds, which is a therapeutic purpose.
No
The device is described as a "tool to generate sounds" to relieve tinnitus and is designed to "generate noise" for the same purpose. It does not perform any diagnostic function.
No
The device is described as firmware embedded within the integrated circuit of a hearing aid, which is a hardware device. While the Multiflex Tinnitus Technology is a software component (firmware), it is not a standalone software-only medical device; it is part of a larger hardware system.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Multiflex Tinnitus Technology is described as a tool to generate sounds for tinnitus management. It is a firmware program embedded in a hearing aid.
- Intended Use: Its intended use is to relieve patients suffering from tinnitus by generating sounds.
- Mechanism of Action: It works by producing auditory stimuli, not by analyzing biological samples.
The device's function and intended use clearly fall outside the scope of In Vitro Diagnostics. It is a therapeutic device delivered through a hearing aid.
N/A
Intended Use / Indications for Use
The Multiflex Tinnitus Technology is a tool to generate sounds to be used in a Tinnitus Management Program to relieve patients suffering from tinnitus. The target population is primarily the adult population over 18 years of age.
The Multiflex Tinnitus Technology is targeted for healthcare professionals, which are treating patients suffering from tinnitus, as well as conventional hearing disorders. The fitting of the Multiflex Tinnitus Technology must be done by a hearing professional participating in a Tinnitus Management Program.
Product codes (comma separated list FDA assigned to the subject device)
KLW
Device Description
Multiflex Tinnitus TechnologyTM (Tinnitus Multiflex) is designed to generate noise that can optionally periodically fluctuate in amplitude and frequency to provide relief for patients suffering from tinnitus.
Tinnitus Multiflex is a firmware program code (algorithm) that is embedded as part of the integrated circuit (IC) in the Digital Signal Processing (DSP) stage of a hearing-aid. More specifically, Tinnitus Multiflex is an added branch of code that is separate from the normal existing hearing-aid firmware. As such, hearing-aid operating characteristics (besides tinnitus-stimulus functionalities) are not impacted by the Tinnitus Multiflex branch of code. Tinnitus Multiflex may be deployed across all Starkey hearing-aid models.
Tinnitus Multiflex functionalities and parameters are enabled and adjusted by a hearing- care professional utilizing the Starkey proprietary hearing-aid programming software, Inspire. The Tinnitus Multiflex can be manually adjusted to a patient's stimulus needs or automatically adjusted via the new audiogram shaping functionality.
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
primarily the adult population over 18 years of age.
Intended User / Care Setting
healthcare professionals
hearing professional participating in a Tinnitus Management Program.
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)
Risk analyses and verification testing were performed for the addition of the audiogram-shaping functionality. Results demonstrated that Tinnitus Multiflex meets the device testing acceptance criteria described in the predicate submission (K122876) and is substantially equivalent to the predicate (Multiflex Tinnitus TechnologyTM).
No new clinical testing was completed, nor relied upon, in support of this Special 510(k).
Changes to the subject device, Tinnitus Multiflex, do not raise new questions of safety or effectiveness. The addition of the audiogram-shaping functionality was assessed by appropriate risk management methodology and addressed with verification and validation testing.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 contains two logos. On the left is the Department of Health & Human Services logo. On the right is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Starkey Laboratories, Inc. Ka Xiong Sr. Regulatory Affairs Specialist 6700 Washington Ave S Eden Prairie, Minnesota 55344
Re: K201370
Trade/Device Name: Multiflex Tinnitus Technology Regulation Number: 21 CFR 874.3400 Regulation Name: Tinnitus Masker Regulatory Class: Class II Product Code: KLW Dated: May 20, 2020 Received: May 22, 2020
Dear Ka Xiong:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for Michael J. Ryan Director DHT1C: Division of ENT, Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K201370
Device Name Multiflex Tinnitus Technology
Indications for Use (Describe)
The Multiflex Timitus Technology is a tool to generate sounds to be used in a Tinnitus Management Program to relieve patients suffering from tinnitus. The target population is primarily the adult population over 18 years of age.
The Multiflex Tinnitus Technology is targeted for healthcare professionals, which are treating patients suffering from timitus, as well as conventional hearing disorders. The fitting of the Multiflex Timitus Technology must be done by a hearing professional participating in a Tinnitus Management Program.
| 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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
| 510(k) Number | K201370 |
|---|---|
| Date Prepared | 19 June 2020 |
| Submitter Name & | |
| Address | Starkey Laboratories, Inc. |
| 6700 Washington Ave. South | |
| Eden Prairie, MN 55344 | |
| Contact Person | Ka Zoua Xiong |
| Senior Regulatory Affairs Specialist | |
| Phone: 952-915-6235 ext.6235 | |
| Email: KaZoua_Xiong@starkey.com | |
| Alternative Contact | |
| Person | Yangjun Xing |
| Senior Regulatory Affairs Manager | |
| Phone: 952-947-4635 ext.4635 | |
| Email: Yangjun Xing@starkey.com | |
| Proprietary/Trade | |
| Name | Multiflex Tinnitus TechnologyTM |
| Common/Usual Name | Tinnitus Masker |
| Product Classification | |
| Code | KLW |
| Product Regulation | |
| Number and Name | 21 CFR § 874.3400 - Tinnitus Masker |
| Device Class | II |
| Predicate Device | Predicate: Multiflex Tinnitus TechnologyTM |
| 510(k) Number: K122876 | |
| Clearance Date: 31 Oct 2012 | |
| Device Description | Multiflex Tinnitus TechnologyTM (Tinnitus Multiflex) is designed to generate noise that |
| can optionally periodically fluctuate in amplitude and frequency to provide relief for | |
| patients suffering from tinnitus. |
Tinnitus Multiflex is a firmware program code (algorithm) that is embedded as part of
the integrated circuit (IC) in the Digital Signal Processing (DSP) stage of a hearing-aid.
More specifically, Tinnitus Multiflex is an added branch of code that is separate from
the normal existing hearing-aid firmware. As such, hearing-aid operating characteristics
(besides tinnitus-stimulus functionalities) are not impacted by the Tinnitus Multiflex
branch of code. Tinnitus Multiflex may be deployed across all Starkey hearing-aid
models.
Tinnitus Multiflex functionalities and parameters are enabled and adjusted by a hearing-
care professional utilizing the Starkey proprietary hearing-aid programming software,
Inspire. The Tinnitus Multiflex can be manually adjusted to a patient's stimulus needs
or automatically adjusted via the new audiogram shaping functionality. |
| Indications for Use/
Intended Use | The Multiflex Tinnitus Technology is a tool to generate sounds to be used in a Tinnitus
Management Program to relieve patients suffering from tinnitus. The target population
is primarily the adult population over 18 years of age.
The Multiflex Tinnitus Technology is targeted for healthcare professionals, which are
treating patients suffering from tinnitus, as well as conventional hearing disorders. The
fitting of the Multiflex Tinnitus Technology must be done by a hearing professional
participating in a Tinnitus Management Program. |
4
| Features | Multiflex Tinnitus TechnologyTM (Subject Device) | Multiflex Tinnitus TechnologyTM (Predicate Device - K122876) | |
|---|---|---|---|
| Intended Use and Indications for Use | Same | The Multiflex Tinnitus Technology is a tool to generate sounds to be used in a Tinnitus Management Program to relieve patients suffering from tinnitus. The target population is primarily the adult population over 18 years of age. |
The Multiflex Tinnitus Technology is targeted for healthcare professionals, which are treating patients suffering from tinnitus, as well as conventional hearing disorders. The fitting of the Multiflex Tinnitus Technology must be done by a hearing professional participating in a Tinnitus Management Program. | |
| Schedule of Use | Same | This device is intended for use for a maximum of sixteen (16) hours a day when set at the maximum output level. | |
| Design Features | Same. | The Multiflex Tinnitus TechnologyTM is designed to generate broadband white noise that periodically fluctuates in amplitude and frequency to provide relief for patients suffering from tinnitus. | |
| Mechanism of Action | The Multiflex Tinnitus TechnologyTM provides a flat stimulus shape (irrespective of patient thresholds) that can be manually adjusted to a patient's stimulus needs.
The Multiflex Tinnitus TechnologyTM can also utilize the Tinnitus audiogram shaping functionality to automatically shape the tinnitus stimulus based on a patient's audiogram. | The Multiflex Tinnitus TechnologyTM provides a flat stimulus shape (irrespective of patient thresholds) that can be manually adjusted to a patient's stimulus needs. | |
| Technological Characteristics | Same | Firmware based, enabled with a hearing-aid programming software (Inspire). | |
| | Performance
Specifications | Same | Max overall output level - 87 dB
SPL |
| | | Same | Max A-weighted overall output - 87
dB SPL |
| | | | Max 1/3 octave output level – 87 dB
SPL |
| | Maximum
Sound
Loudness
Output | Same | Maximum output in a 2cc coupler
limited to 87 dB SPL. |
| | Volume
Control | Same | Tinnitus output levels are set to
specified limits by the hearing-care
professional. The patient
volume/level controls can be enabled
to provide adjustments that can
decrease or increase output levels
within set limits. |
| | Power Source | Same | May use any 1.4V hearing-aid
battery (size 13, 312 or 10) or be
rechargeable. |
| Summary of Non-
Clinical Testing | Risk analyses and verification testing were performed for the addition of the audiogram-
shaping functionality. Results demonstrated that Tinnitus Multiflex meets the device
testing acceptance criteria described in the predicate submission (K122876) and is
substantially equivalent to the predicate (Multiflex Tinnitus Technology™). | | |
| Summary of Clinical
Testing | No new clinical testing was completed, nor relied upon, in support of this Special
510(k). | | |
| | Changes to the subject device, Tinnitus Multiflex, do not raise new questions of safety
or effectiveness. The addition of the audiogram-shaping functionality was assessed by
appropriate risk management methodology and addressed with verification and
validation testing. | | |
| Statement of
Equivalence | Acoustic measurements of output levels, utilizing previously defined limits, were used
during verification to ensure that the maximum allowable stimulus level for the subject
device was the same as the predicate device. All results passed, and the results of the
verification and validation testing support that the addition of the audiogram-shaping
functionality does not impact safety and effectiveness. | | |
| | The subject and predicate devices are technologically identical and neither the subject
device safety and effectiveness, nor intended use is impacted. The results support
substantial equivalence of the subject device to the predicate device (K122876). | | |
5