(260 days)
Intrisound™ Tuned Lumen® 155 are self-fitting, wireless air conduction hearing aids, intended to amplify sound for individuals 18 years of age or older with perceived mild to moderate hearing impairment. They are to meet the user's hearing needs. The device is intended for use without the assistance of a hearing care professional.
The Intrisound™ Tuned Lumen® 155 Hearing Aid is a wireless, self-fitting air conduction hearing aid. It features digital signal processing (16 channel wide dynamic input compression, 3 layer fastacting output compression, 16 channel noise reduction, feedback cancellation), bi-directional microphone with windscreen, volume and program control, 12 band equalizer, self-selectable tube and ear tips, and customization through the Tuned Mobile Application. The Tuned Mobile Application aims to detect accurate auditory thresholds, partnering with a smart phone application to deliver user-customized sound through the Intrisound™ Tuned Lumen® 155 Hearing Aid. These thresholds are used to program the device using a proprietary algorithm.
The provided text describes the acceptance criteria and the studies conducted for the Intrisound™ Tuned Lumen® 155 Hearing Aids.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not present a single, consolidated table specifically labeled "Acceptance Criteria and Reported Device Performance" in the typical format of a summary table for a medical device. However, the STUDY 1 section clearly outlines acceptance criteria for various endpoints and then immediately follows with the reported results for those criteria. Similarly, Table 2 and Table 3 detail performance characteristics against standards.
Let's synthesize the information specifically from STUDY 1 and relevant tables:
Acceptance Criteria and Reported Device Performance for Intrisound™ Tuned Lumen® 155 Hearing Aids
| Acceptance Criteria (Study 1, Section 10) | Reported Device Performance (Study 1 Results) |
|---|---|
| Mean Absolute Difference (MAD) of less than 10 dB for each tested frequency (500, 1000, 2000, 4000 Hz) between Tuned self-test and traditional audiometry. | Total MAD (averaged over all tested frequencies) was 5.25 dB (95% CI: 4.73 to 5.78 dB), which is well within 10 dB. Frequencies were well correlated. |
| Total MAD of less than 10 dB between Tuned self-test and traditional audiometry. | Total MAD was 5.25 dB (95% CI: 4.73 to 5.78 dB), well within 10 dB. |
| Tuned self-fitting is non-inferior to professional fitting by showing that the MAD from NAL-NL2 targets per frequency of the Tuned self-fitting is within the range of 5 dB of the MAD from NAL-NL2 of the professional fitting. | The MAD from NAL-NL2 per frequency of the Tuned self-fitting is well within the range of 5 dB of the MAD from NAL-NL2 of the professional fitting. |
| The total MAD from NAL-NL2 targets of the Tuned self-fitting is within the range of 5 dB. | The total MAD from NAL-NL2 targets for Tuned self-fitting is 3.37 dB (95% CI: 3.2 to 3.53 dB), well within 5 dB. |
| The total MAD of the Real Ear Aided Responses (REAR) of the Tuned self-fitting and the professional fitting is in the range of 5 dB. | The total MAD between the REAR of professional-fitting and Tuned self-fitting is 3.72 dB (95% CI: 3.55 to 3.89 dB), well within 5 dB. |
| The maximum power output (MPO) measurements do not exceed 117 dB SPL in any volume control level. | All MPO measurements in the real ear were less than 117 dB SPL in all volume control levels. |
| Additional Performance Characteristics (from Table 2 & Table 8: ANSI ASA S3.22 Performance Data) | Reported Device Performance |
| Max OSPL90 (for OTC hearing aids per 21CFR800.30) | 114.4 dB SPL (Lower than predicate's 120 dB SPL to comply with OTC requirements) |
| High Frequency Average OSPL90 (HFA OSPL90) | 109.6 ± 2 dB SPL (Meets requirements of the standard) |
| High Frequency Average Full-on Gain (HFA FOG) | 40 ± 2 dB (Meets requirements of the standard) |
| Reference Test Gain (RTG) | 34 ± 4 dB (Meets requirements of the standard) |
| Frequency Response | 200 Hz to 8000 Hz (Meets requirements of the standard) |
| Frequency Range | <200 Hz to 7100 Hz (Difference noted due to Receiver-in-Aid acoustic bandwidth limitations, but does not introduce new safety/effectiveness concerns, supported by performance testing). |
| Harmonic Distortion (for OTC hearing aids per ANSI CTA 2051-2017 and 21CFR800.30) | 500 Hz ≤ 5.0%, 800 Hz ≤ 5.0%, 1600 Hz ≤ 5.0% (Complies with < 5% requirement). |
| Equivalent Input Noise (EIN) | <27 dB SPL (Meets requirements of the standard) |
| Battery Current | 1.2 mA (Meets requirements of the standard) |
| Latency (per ANSI CTA 2051-2017) | Complies with ≤ 15 ms requirement. |
2. Sample sizes used for the test set and data provenance
STUDY 1 (Clinical Performance Validation):
- Sample Size: 30 participants (adults).
- Data Provenance: Retrospective or Prospective is not explicitly stated as a separate point; however, the study design section states it was a "prospective, crossover, comparative study." The recruitment from "private hearing clinics" suggests the data is likely sourced from the country where these clinics are located, but the country of origin is not explicitly stated.
STUDY 2 (Subjective Outcome Comparison - COSI/IOI-HA):
- Sample Size: 41 participants (N=41 completed the study: 20 in Group 1, 21 in Group 2).
- Data Provenance: "Prospective, two-arm, two-site, crossover randomized controlled and comparative study." Similar to Study 1, the country of origin is not explicitly stated. Given the context of FDA submission, it's typically assumed to be North America or Europe unless otherwise specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
STUDY 1:
- Number of Experts: Not explicitly specified as a distinct number, but the study compared the Tuned self-test to "traditional audiometry performed by a professional" and "licensed audiologist." This implies at least one, if not multiple, qualified professionals.
- Qualifications of Experts: "Licensed audiologist" and "professional." No specific experience (e.g., "10 years of experience") is mentioned.
STUDY 2:
- Number of Experts: Not explicitly stated as a distinct number. The study compared self-fitting to "licensed professional fitting." This implies the involvement of one or more licensed professionals to perform the "professional fitting."
- Qualifications of Experts: "Licensed professional." No specific experience mentioned.
4. Adjudication method for the test set
The provided text does not mention any adjudication method for the test sets in either Study 1 or Study 2. The comparisons are direct between the device's output/self-fitting outcome and the professional's assessment/fitting outcome.
5. If a Multi Reader Multi Case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
An MRMC comparative effectiveness study was not explicitly described in the provided text. The studies focus on comparing the self-fitting hearing aid's performance/user outcomes against traditional audiology methods, rather than assessing how human readers (e.g., radiologists, ophthalmologists) improve with AI assistance. The device is a self-fitting hearing aid, not an AI-powered diagnostic imaging tool that assists human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, in essence, standalone performance was assessed for the self-fitting capability.
- Study 1 directly compared the "Tuned self-test" (algorithm-driven self-assessment) against "traditional audiometry performed by a professional" for auditory thresholds. This can be considered a form of standalone evaluation for the audiometric threshold detection aspect of the device's algorithm.
- The "Intrisound™ Tuned Lumen® 155 Hearing Aid is a wireless, self-fitting air conduction hearing aid... customization through the Tuned Mobile Application. The Tuned Mobile Application aims to detect accurate auditory thresholds, partnering with a smart phone application to deliver user-customized sound through the Intrisound™ Tuned Lumen® 155 Hearing Aid. These thresholds are used to program the device using a proprietary algorithm." This describes the core standalone functionality of the device's self-fitting algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Study 1: The ground truth for audiometric thresholds was established by traditional audiometry performed by a licensed professional (audiologist). For fitting parameters (NAL-NL2 targets, REAR), the ground truth was based on established audiology standards and professional fitting methods.
- Study 2: The ground truth for subjective outcomes was established using validated patient-reported outcome measures (PROMs) - COSI and IOI-HA questionnaires completed by the participants themselves, after using both self-fitting and professional fitting methods. This is a form of user-reported outcomes data. The "professional fitting" condition serves as a comparative reference for the self-fitting's effectiveness.
8. The sample size for the training set
The document does not specify the sample size for the training set used to develop the proprietary algorithm or the Tuned self-test. The studies described are performance validation/testing studies, not algorithm development studies.
9. How the ground truth for the training set was established
Since the training set size or methodology is not detailed, the document does not provide information on how the ground truth for the training set was established.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
September 8, 2023
Tuned Ltd % Shoshana (Shosh) Friedman Senior Regulatory Affairs Consultant (ProMedoss, Inc.) ProMedoss Inc 3521 Hatwynn Road Charlotte, North Carolina 28269
Re: K223848
Trade/Device Name: Intrisound™ Tuned Lumen® 155 Hearing Aids Regulation Number: 21 CFR 874.3325 Regulation Name: Self-Fitting Air-Conduction Hearing Aid Regulatory Class: Class II Product Code: QUH Dated: August 10, 2023 Received: August 11, 2023
Dear Shoshana (Shosh) Friedman:
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
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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 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/cdrl-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,
Shuchen Peng -S Shu-Chen Peng, Ph.D. Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
Device Name Intrisound™M Tuned Lumen® 155 Hearing Aids
Indications for Use (Describe)
Intrisound™ Tuned Lumen® 155 are self-fitting, wireless air conduction hearing aids, intended to amplify sound for individuals 18 years of age or older with perceived mild to moderate hearing impairment. They are to meet the user's hearing needs. The device is intended for use without the assistance of a hearing care professional.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/0 description: The image shows the logo for Tuned. The logo consists of a stylized "C" shape made up of concentric arcs in shades of blue and purple, followed by the word "TUNED" in a simple, sans-serif font. A small "TM" symbol is placed to the upper right of the word "TUNED".
510(K) SUMMARY Intrisound™ Tuned Lumen® 155 Hearing Aids 510(k) Number K223848
1. SUBMITTER
Applicant's Name and Address: Tuned Ltd. 18 Harimon St, Gan Yoshiya Israel, 3885000
Primary Contact: Shoshana (Shosh) Friedman Senior Regulatory Affairs Consultant Phone: (704) 430-8695 Email: s.friedman@promedoss.com
510(k) Summary Prepared on: September 5, 2023
2. SUBJECT DEVICE
Trade Name: Intrisound™ Tuned Lumen® 155 Hearing Aids
Classification: Name: Self-Fitting Air-Conduction Hearing Aid, Over The Counter Product Code: OUH Regulation No: 21 CFR 874.3325 Class: 2 Review Panel: Ear Nose & Throat
3. PREDICATE DEVICE
BHA100 Series Braun® Clear™ Hearing Aid cleared under K212609
REFERENCE DEVICE বঁ
None
DEVICE DESCRIPTION 5.
The Intrisound™ Tuned Lumen® 155 Hearing Aid is a wireless, self-fitting air conduction hearing aid. It features digital signal processing (16 channel wide dynamic input compression, 3 layer fastacting output compression, 16 channel noise reduction, feedback cancellation), bi-directional microphone with windscreen, volume and program control, 12 band equalizer, self-selectable tube and ear tips, and customization through the Tuned Mobile Application. The Tuned Mobile Application aims to detect accurate auditory thresholds, partnering with a smart phone application to deliver user-customized sound through the Intrisound™ Tuned Lumen® 155 Hearing Aid. These thresholds are used to program the device using a proprietary algorithm.
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Image /page/4/Picture/0 description: The image shows the logo for Tuned. The logo consists of a stylized sound wave icon on the left, followed by the word "TUNED" in a sans-serif font. A small trademark symbol is located to the upper right of the word "TUNED".
INTENDED USE/INDICATIONS FOR USE 6.
The Intrisound™ Tuned Lumen® 155 are self-fitting, wireless air conduction hearing aids, intended to amplify sound for individuals 18 years of age or older with perceived mild to moderate hearing impairment. They are adjusted by the user's hearing needs. The device is intended for use without the assistance of a hearing care professional.
7. LABELING
Self-selection labeling has been included in the Intrisound™ Tuned Lumen® 155 Hearing Aid User Manual (UM) to mitigate the risk of improper self-selection. The information includes the following:
- Identifying situations in which the Intrisound™ Tuned Lumen® 155 Hearing Aid may help . users hear better.
- . Identifying situations in which the Intrisound™ Tuned Lumen® 155 Hearing Aid may not be right for users.
- Identifying criteria that indicate users should see a hearing professional. .
- . Informing users that the Intrisound™ Tuned Lumen® 155 Hearing Aid will not restore normal hearing.
- Informing users that it is good health practice to have hearing loss evaluated by a licensed . healthcare professional.
Additionally, the Intrisound™ Tuned Lumen® 155 Hearing Aid User Manual (UM) contains information about the Remote Support Service and the Call Center Telephone Support Service that is available to the users to address concerns and optimize product functionality.
8. SPECIAL CONTROLS
The Intrisound™ Tuned Lumen® 155 Hearing Aid conforms to the special controls stated in 21 CFR 874.3325. These requirements were satisfied through the following:
- Clinical Performance Validation ●
- Non-Clinical Performance Testing .
- Summative Usability / Human Factors Validation ●
- . Labeling
9. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
The Intrisound™ Tuned Lumen® 155 Hearing Aid has the same intended use and fundamental technology as the predicate device , the BHA100 Series Braun® Clear™ Hearing Aid. In the same manner as its predicate device, the Intrisound™ Tuned Lumen® 155 Hearing Aid a user-fitted wireless air-conduction hearing aid intended for over-the-counter use by individuals 18 years or older with perceived mild to moderate hearing impairment.
The same fundamental scientific technology is present in both hearing aids to allow the user to control and customize the device to the user's hearing needs. The subject device is essentially equivalent to the predicate device in product design, dimension, use of Bluetooth technology and utilizing biocompatible materials of high standard.
Table 1 below provides a summarized comparison between the subject device and the predicate device.
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Image /page/5/Picture/0 description: The image shows the logo for Tuned. The logo consists of a stylized sound wave icon on the left and the word "TUNED" in a sans-serif font on the right. The sound wave icon is made up of three concentric arcs in shades of blue and purple. The TM symbol is located in the upper right corner of the word "TUNED".
Table 1: Comparison Table
| Characteristic | PREDICATE DEVICEBHA100 Series Braun®Clear™ Hearing Aid | SUBJECT DEVICEIntrisound™ TunedLumen® 155Hearing Aid | Comparison Analysis |
|---|---|---|---|
| 510(k) Number | K212609 | K223848 | NA |
| Product Code | QDD | QUH | The OTC version of the self-fitting hearing aid has adifferent product code (QUH)than when the predicate devicewas originally cleared as aself-fitting hearing aid. Theonly differences relevant tothis change are updatedlabeling, design, andperformance characteristicsrequired by 800.30 for OTChearing aids by the enactmentof the OTC Hearing Aid FinalRule that became effective onOctober 17, 2022 |
| Regulation | 21 CFR 874.3325 | 21 CFR 874.3325 | Same |
| ClassificationName | Self-Fitting Air-ConductionHearing Aid, Prescription | Self-Fitting Air-ConductionHearing Aid, Over TheCounter | - |
| Intended Use | The BHA100 Series Braun®Clear™ Hearing Aid is aself-fitting, air conductionhearing aid, intended toamplify sound for individuals18 years of age or older withperceived mild to moderatehearing impairment. It isadjusted by the user to meetthe user's hearing needs. Thedevice is intended for direct-to-consumer sale and usewithout the assistance of ahearing health careprofessional. | The Intrisound™ TunedLumen® 155 are self-fitting,wireless air conductionhearing aids, intended toamplify sound for individuals18 years of age or older withperceived mild to moderatehearing impairment. They areadjusted by the user to meetthe user's hearing needs. Thedevice is intended for usewithout the assistance of ahearing healthcareprofessional. | The intended use of the subjectdevice is similar to theintended use of the predicatedevice with the appropriateadjustment in accordance withthe OTC Hearing Aid FinalRule. |
| DeviceDescription | The BHA100 Series Braun®Clear™ Hearing Aid is aself-fitting, air conductionhearing aid. It features digitalsignal processing (16channel-wide dynamic inputcompression, 3 channel fast-acting output compression,16 channel noise reduction,feedback cancellation) | The Intrisound™ TunedLumen™ 155 Hearing Aid isa wireless, self-fitting airconduction hearing aid. Itfeatures digital signalprocessing (16 channel widedynamic input compression,3 layer fast-acting outputcompression, 16 channelnoise reduction, feedback | The two devices are similar,with additional equalizeradjustments in the subjectdevice, which do not introduceany new safety or effectivenessconcerns. Performance testingsupports the substantialequivalence. |
| Characteristic | PREDICATE DEVICEBHA100 Series Braun®Clear™ Hearing Aid | SUBJECT DEVICEIntrisound™ TunedLumen® 155Hearing Aid | Comparison Analysis |
| directional microphone withwindscreen, volume andprogram control(environment selection –Quiet, Noisy, Concert, TV), 3channel equalizer, self-adjustable wire and ear tips,and customization throughthe Braun® Clear™ MobileApplication. The Braun®ClearCheck™ Hearing Testaims to detect accurateauditory thresholds,partnering with a smartphone application to deliveruser-customized soundthrough the Braun® Clear™Hearing Aid. Thesethresholds are used toprogram the device using aproprietary fitting algorithm. | cancellation), bi-directionalmicrophone with windscreen,volume and program control,12 band equalizer, self-selectable tube and ear-tip(dome), and customizationthrough the Tuned MobileApplication. The TunedMobile Application aims todetect accurate auditorythresholds, partnering with asmart phone application todeliver user-customizedsound through theIntrisound™ Tuned Lumen®155 Hearing Aid. Thesethresholds are used toprogram the device using aproprietary algorithm. | ||
| Technology | Wireless, self-fitting airconduction hearing aid | Wireless, self-fitting airconduction hearing aid | Same |
| Housing | BTE (Receiver-in-Canal) | BTE (Receiver-in-Aid) | SimilarBoth devices are BTE with adifference being that thesubject device uses theReceiver-in-Aid assemblyinstead of a Receiver-in-Canalassembly.Performance testing supportsthe substantial equivalence. |
| Power On-Off | Through battery door:Closed = power ONOpen = power OFF | Through battery door:Closed = power ONOpen = power OFF | Same |
| Ear-Tips | Two models: Open dome(sizes S, M, L), Closed dome(sizes S, M, L) | Three models: Tulip dome(one size); Double dome(sizes S, M, L), Open dome(sizes S, M, L) | Similar.The subject device offers anadditional ear-tip model.Performance testing supportsthe substantial equivalence |
| Mobile App | Mobile application on asmartphone with either iOSor Android platforms. | Mobile application on asmartphone with either iOSor Android platforms. | Same |
| WirelessCommunication | Bluetooth protocol | Bluetooth protocol | Same |
| Wireless UserControl Functions | Volume control, programchange selection, settings | Volume control, programchange selection, settings | Same |
| Characteristic | PREDICATE DEVICEBHA100 Series Braun®Clear™ Hearing Aid | SUBJECT DEVICEIntrisound™ TunedLumen® 155Hearing Aid | Comparison Analysis |
| Bluetooth Pairingand Control | Pairing and controlverification with the pairedmobile device. | Pairing and controlverification with pairedmobile device. | Same |
| Power Source | Replaceable, disposable, 1.45Volt, size 312, zinc airbattery | Replaceable, disposable, 1.45Volt, size 312, zinc airbattery | Same |
| Microphones | Bi-directional microphoneswith windscreen | Bi-directional microphoneswith windscreen | Same |
| Device Control | On device and throughmobile app | On device and throughmobile app | Same |
| Compression | 16 channel, input controlled,output limiting | 16 channel, input controlled,output limiting | Same |
| Noise Reduction | 16 channel | 16 channel | Same |
| FeedbackCancellation | Adaptive | Adaptive | Same |
| Telephone Calls | None | None | Same |
| Self-FittingMethod | NAL-NL2 based | NAL-NL2 based proprietyalgorithm | Similar.Performance testing supportsthe substantial equivalence. |
| Remote FirmwareUpdate | None | None | Same |
| Latency | Complies with ANSI CTA2051-2017 which requireslatency ≤ 15 ms | Complies with (e)(3) of 21CFR 800.30 and with ANSICTA 2051-2017 whichrequires latency ≤ 15 ms | Similar.Performance testing supportsthe substantial equivalence. |
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Image /page/6/Picture/0 description: The image shows the logo for Tuned. The logo consists of a stylized sound wave icon on the left and the word "TUNED" in a sans-serif font on the right. The sound wave icon is made up of concentric arcs in shades of blue and purple. The letters in "TUNED" are a dark blue color, and there is a small "TM" symbol in the upper right corner of the word.
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Image /page/7/Picture/0 description: The image shows the logo for Tuned. The logo consists of a stylized sound wave icon on the left and the word "TUNED" in a sans-serif font on the right. The sound wave icon is made up of concentric arcs in shades of blue and purple, while the word "TUNED" is in a dark blue color, with a trademark symbol in the upper right corner.
ANSI ASA S3.22 Specification of Hearing Aid Characteristics
In order to demonstrate substantial equivalence with the predicate device, the Intrisound™ Tuned Lumen® 155 Hearing Aid was evaluated per ANSI ASA S3.22 for acoustic performance. These results are summarized in Table 2 below.
| Characteristic | PREDICATE DEVICEBHA100 Series Braun®Clear™ Hearing Aid | SUBJECT DEVICEIntrisound™ TunedLumen® 155Hearing Aid | Comparison Analysis |
|---|---|---|---|
| OSPL90 Curve | Image: Graph of OSPL90 Curve for PREDICATE DEVICE | Image: Graph of Frequency Response - Left and dB Gain for SUBJECT DEVICE | Comparable.Performance testing supportsthe substantial equivalence. |
Table 2: ANSI ASA S3.22 Performance Data
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Image /page/8/Picture/0 description: The image shows the logo for Tuned. The logo consists of a stylized sound wave icon on the left and the word "TUNED" in a sans-serif font on the right. The sound wave icon is made up of concentric arcs in shades of blue and purple. The TM symbol is located to the upper right of the word TUNED.
| Characteristic | PREDICATE DEVICEBHA100 Series Braun®Clear™ Hearing Aid | SUBJECT DEVICEIntrisound™ TunedLumen® 155Hearing Aid | Comparison Analysis |
|---|---|---|---|
| Max OSPL90 | 120 dB SPL | 114.4 dB SPL | The maximum output of thesubject device is lower than thepredicate device to complywith the requirements of21CFR800.30 for OTC hearingaids.Performance testing supportsthe substantial equivalence. |
| High FrequencyAverage OSPL90(HFA OSPL90) | 111 ± 2 dB SPL | 109.6 ± 2 dB SPL | Both devices meet therequirements of the standard. |
| High FrequencyAverage Full-onGain (HFA FOG) | 40 ± 2 dB | 40 ± 2 dB | Both devices meet therequirements of the standard. |
| Reference TestGain (RTG) | 34 ± 4 dB | 34 ± 4 dB | Both devices meet therequirements of the standard. |
| FrequencyResponse | 200 Hz to 8000 Hz | 200 Hz to 8000 Hz | Both devices meet therequirements of the standard. |
| Frequency Range | <200-8000 Hz | <200 Hz to 7100 Hz | Difference in range is due tothe acoustic bandwidthlimitations of the Receiver-in-Aid. This difference does notintroduce new safety oreffectiveness concerns andperformance testing supportsthe substantial equivalence. |
| HarmonicDistortion | From Engineering ProductSpecifications:500 Hz ≤ 1.5%800 Hz ≤2.0%1600 Hz ≤ 3.0% | 500 Hz ≤ 5.0%800 Hz ≤ 5.0%1600 Hz ≤ 5.0% | The subject device complieswith ANSI CTA 2051-2017and 21CFR800.30 that requirestotal harmonic distortion to beless than 5%. |
| Equivalent InputNoise (EIN) | <29 dB SPL | <27 dB SPL | Both devices meet therequirements of the standard. |
| Battery Current | 2.5 mA | 1.2 mA | Both devices meet therequirements of the standard. |
ANSI ASA S3.6 Specifications for Audiometers
Like the Braun® ClearCheck™ Hearing Test feature of the predicate device, the BHA100 Series Braun® Clear™ Hearing Aid, also the Tuned App of the Intrisound™ Tuned Lumen® 155 Hearing Aid was designed to conform to the applicable clauses of ANSI ASA S3.6, as listed in Table 3.
| Table 3: ANSI ASA S3.6 Applicable Clauses | ||||
|---|---|---|---|---|
| ------------------------------------------- | -- | -- | -- | -- |
| Clause # | Clause Title |
|---|---|
| 5.4.3 | Unwanted sounds from an earphone |
| 6.1.1 | Frequencies and hearing levels |
| 6.1.4 | Frequency accuracy |
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Image /page/9/Picture/0 description: The image shows the word "TUNED" in a sans-serif font. To the left of the word is a graphic of three curved lines that resemble sound waves. The color of the graphic transitions from light blue to dark blue to purple. The letters of the word "TUNED" are black, and there is a trademark symbol in the upper right corner of the letter D.
| Clause # | Clause Title |
|---|---|
| 6.1.5 | Harmonic distortion |
| 7.2 | Accuracy of sound pressure for pure tone |
| 7.3.1 | Hearing level control increments |
| 7.3.3 | Hearing level control linearity |
| 7.5.2 | On/off ratio |
10. CLINICAL PERFORMANCE TESTING
The clinical performance of the Intrisound™ Tuned Lumen® 155 Hearing Aid was evaluated in several studies. Presented below are the two recent studies.
STUDY 1: TU1-RPT-433, Tuned self-test and Tuned self-fitting outputs in comparison with professional hearing test and fitting outputs of hearing-impaired participants
Studv Design
This study of the Intrisound™ Tuned Lumen® 155 Hearing Aid was a prospective, crossover, comparative study designed to validate results of the Tuned self-test compared to a traditional audiometry performed by a professional. In particular, this study aimed to validate a mean absolute difference (MAD) of less than 10 dB for each tested frequency (500, 1000, 2000 and 4000 Hz) between the Tuned self-test and the traditional audiometry and a total MAD1 of less than 10 dB. This study also aimed to demonstrate that:
- Tuned self-fitting is non inferior to the professional fitting by showing that the MAD from । NAL-NL2 per frequency of the Tuned self-fitting is within the range of 5 dB of the MAD from NAL-NL2 of the professional fitting.
- The total MAD of the Tuned self-fitting is within the range of 5 dB from the NAL-NL2 targets. -
- The total MAD of the real ear aided responses (REAR) of the Tuned self-fitting and the professional fitting is in the range of 5 dB.
- The maximum power output (MPO) measurements do not exceed 117 dB SPL in any volume control level.
The acceptance criteria presented above were set in accordance to the acceptance criteria applied in the clinical study of the predicate device, the BHA100 Series Braun® Clear™ Hearing Aid, to support the substantial equivalence determination.
The crossover was applied by assigning half of the participants (odd participant numbers) to start with the standard clinical audiometry by a professional, then performed a hearing self-test while the other half (even participant numbers) started with performing the hearing test by themselves, then tested by a professional using standard clinical audiometry.
Study Populations
The study was conducted among a population of 30 adults recruited from private hearing clinics. Table 4 below provides information on the study population.
| Characteristic | N / Total (%) |
|---|---|
| Age | |
| 18 to 40 years of age | 3 / 30 (10.0%) |
| 41 to 60 years of age | 4 / 30 (13.3%) |
Table 4: Study 1 Population Summary
1 "Total MAD" is the average MAD of all averaged over all tested frequencies.
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Image /page/10/Picture/0 description: The image shows the logo for Tuned. The logo consists of a stylized graphic of concentric circles in shades of blue and purple, followed by the word "TUNED" in a simple, sans-serif font. A trademark symbol appears to the upper right of the word.
| Characteristic | N / Total (%) |
|---|---|
| 61 to 70 years of age | 7/30 (23.3%) |
| 71 to 80 years of age | 15 / 30 (50.0%) |
| 81 years of age and up | 1 / 30 (3.3%) |
| Sex | |
| Female | 15 / 30 (50.0%) |
| Male | 15 / 30 (50.0%) |
| Symmetric/Asymmetric Hearing Loss | |
| Symmetric | 21 / 30 (70.0%) |
| Asymmetric | 9 / 30 (30.0%) |
| Previous Experience with Hearing Aids | |
| Experienced User | 18 / 30 (60.0%) |
| New User | 12 / 30 (40.00%) |
Study Results
The results of the primary endpoint, namely, the measured audiometric threshold for each tested frequency of Tuned self-test versus those measured by a licensed audiologist well correlated as shown in Figure 1(a). The mean and ±1 standard deviation of the hearing thresholds, per frequency, obtained by the Tuned self-test and by traditional clinical audiometry performed by a professional are shown in Figure 1(b). The total MAD of the Tuned self-test and the traditional audiometry performed by a professional averaged for all tested frequencies, shown in Figure 1(b), was 5.25 dB with a 95% confidence interval of 4.73 to 5.78 dB, which is well within the accepted criterion of less than 10 dB.
Image /page/10/Figure/4 description: The image is a boxplot comparing hearing thresholds in dB HL for a tuned self-test versus traditional audiometry by a professional. The x-axis represents frequency in Hz, with values of 500, 1000, 2000, and 4000. The y-axis represents hearing thresholds in dB HL, ranging from 0 to 90. The boxplots show the distribution of hearing thresholds for each frequency, with the tuned self-test generally showing lower thresholds than traditional audiometry.
Figure 1(a): Measured Audiometric Thresholds per Frequency
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Image /page/11/Picture/0 description: The image contains the word "TUNED" in a sans-serif font. To the left of the word is a graphic of concentric circles in shades of blue and purple. The letters of the word "TUNED" are in a dark blue color. The letters are all capitalized, and there is a trademark symbol to the right of the word.
Figure 1(b): Mean and ± 1 standard deviation of the hearing thresholds obtained by the Tuned selftest (Blue) and traditional clinical audiometry performed by a professional (Orange), per frequency
Image /page/11/Figure/2 description: The image shows a graph comparing hearing thresholds at different frequencies using two methods: a tuned self-test and traditional audiometry by a professional. The x-axis represents frequency in Hertz (Hz), with values at 500, 1000, 2000, and 4000 Hz. The y-axis represents hearing thresholds in decibels Hearing Level (dB HL), ranging from 0 to 80. The graph indicates that hearing thresholds generally increase with frequency for both methods, with traditional audiometry showing slightly higher thresholds than the tuned self-test.
The results of the secondary endpoints showed that:
- The MAD from NAL-NL2 per frequency of the Tuned self-fitting is well within the range of -5 dB of the MAD from NAL-NL2 of the professional fitting.
- The Tuned self-fitting MAD from NAL-NL2 for each frequency is less than 5 dB and the total -MAD from NAL-NL2 is 3.37 dB with a 95% Confidence Interval of 3.2 to 3.53 dB, well withing the acceptance criterion of 5 dB.
- The total MAD between the REAR of professional-fitting and Tuned self-fitting is 3.72 dB with a 95% Confidence Interval of 3.55 to -3.89 dB, well within the 5 dB acceptance criterion (see Figure 1(c)).
- All MPO measurements in the real ear were less than 117 dB SPL, well within the acceptance criterion of <117 dB SPL in all volume control levels.
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Image /page/12/Picture/0 description: The image shows the logo for Tuned. The logo consists of a stylized sound wave icon on the left, followed by the word "TUNED" in a clean, sans-serif font. A trademark symbol is located to the upper right of the word "TUNED".
Image /page/12/Figure/1 description: The image contains the title of a figure, specifically "Figure 1(c)". The figure displays the mean plus or minus one standard deviation of the REAR, which follows the Tuned self-fitting (Blue) and the professional Autofit (Orange). The data is presented per frequency. The title indicates that the figure likely compares the performance or characteristics of two different fitting methods, with the colors blue and orange used to distinguish between them.
Image /page/12/Figure/2 description: The figure is a plot of REAR (dB SPL) vs Frequency (Hz). The x-axis shows the frequency in Hz, ranging from 250 to 6000. The y-axis shows the REAR in dB SPL, ranging from 0 to 100. There are two lines plotted on the graph, one for 'Tuned self-fitting' and one for 'Professional Autofit', with error bars at each point.
In conclusion, this study supports the clinical performance of the Tuned solution, namely, the Tuned application with the Intrisound Lumen 155 hearing aids, and demonstrates that the Tuned solution is substantially equivalent to the predicate device, the BHA100 Series Braun® Clear™ Hearing Aid, without raising any new safety or effectiveness concerns.
STUDY 2: A prospective, crossover randomized controlled trial to compare subjective outcome of a self-fitting process using Tuned App to a licensed professional fitting (NCT05869266)
Study Design
This study was a prospective, two-arm, two-site, crossover randomized controlled and comparative study, comparing outcomes of two fitting approaches, self-fitting with Tuned mobile app and licensed professional fitting with the same hearing aid device.
Note: Due to the inherent clinician involvement in the tuning process, this study was not investigator-blinded, nevertheless, the meticulous structure of the study aimed to ensure that the lack of blinding did not impact the effectiveness outcomes of the study.
Study Objectives
The primary objective of the study was to compare the subjective outcomes of a self-fitting of the hearing aids done by the participant using the Tuned application and subjective fitting outcomes performed by a licensed professional using the standardized and validated Client Oriented Scale of Improvement (COSI) questionnaire tool.
The secondary objectives were to:
- Compare the subjective outcomes of a self-fitting of the hearing aids done by the 1. participant using the Tuned application and subjective fitting outcomes performed by a
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Image /page/13/Picture/0 description: The image shows the logo for Tuned. The logo consists of a stylized sound wave icon on the left and the word "TUNED" in a sans-serif font on the right. The sound wave icon is made up of concentric arcs in shades of blue and purple. The "TM" symbol is located in the upper right corner of the word "TUNED".
licensed professional using the standardized and validated International Outcome Inventory- Hearing Aids (IOI-HA) questionnaire tool.
- Estimate the rate of device and self-fitting related adverse events. 2.
Study Design & Procedures
In this prospective, two-arm, crossover randomized controlled and comparative study, two fitting approaches using the same hearing aid device were compared - self-fitting with Tuned mobile app and fitting by a licensed professional.
The overall flow of the study is presented in Figure 2 below.
Image /page/13/Figure/6 description: This image is a flowchart that shows the process of a study. The study has two groups, Group 1 and Group 2, and each group goes through a series of steps. The first step is a screening and baseline visit, followed by either self-fitting or pro-fitting depending on the group. After that, there is a phone visit, 2 weeks at home, and a crossover visit. Finally, the study ends with either pro-fitting or self-fitting depending on the group.
Figure 2: Overall Study Flow
Participants in this study underwent the following procedures:
Visit 1: Screening and Eligibility
Upon completion of the informed consent process, subjects underwent a screening process, which included a clinical hearing test conducted by a licensed professional. Subsequently, participants
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Image /page/14/Picture/0 description: The image shows the logo for Tuned. The logo consists of a stylized icon resembling sound waves emanating from a central point, followed by the word "TUNED" in a clean, sans-serif font. A trademark symbol is placed to the upper right of the word "TUNED".
received hearing aids (HA) along with user manuals. Random assignment placed them into one of two groups:
Group 1: Participants received HA fitting performed by a licensed professional using professional programming tools and the thresholds obtained from traditional audiometry.
Group 2: Participants were provided with Instructions for Use (IFU) and were directed to download the TUNED self-fitting App. They performed self-fitting of the HAs, including a selfhearing test.
Visit 2 and 4: Phone visit
Three (3) days after each fitting, participants were contacted to ensure that the device was functioning properly. If needed, participants were invited to visit the site for technical issue resolution.
Visit 3: Crossover Visit
During this visit, all participants were asked to complete the COSI and the IOI-HA questionnaires. The crossover occurred between Group 1 and Group 2. Participants in Group 1 switched to selffitting and performed the same actions as Group 2 during their initial visit. Participants IN Group 2 switched to professional fitting and performed the same actions as Group 1 during their initial visit.
Visit 5: End of study
During this final visit, all participants completed the COSI and IOI-HA questionnaires. Participants in Group 1 had their HAs re-fitted by a licensed professional. Finally, all participants received the HAs they had been using throughout the study.
Study Population
The study was completed by a total of forty-one (N=41) participants. Among them, twenty (N=20) participants initially underwent the professional fitting (Group 1) and later transitioned to Tuned self-fitting and twenty-one (N=21) participants began with Tuned self-fitting (Group 2) and subsequently switched to professional fitting. The demographics and baseline characteristics of the study participants, encompassing gender, age and prior experience with hearing aids, is summarized in Table 5.
| Variable | N | % | Mean | SD | Range | |
|---|---|---|---|---|---|---|
| Gender | Male | 19 | 46.3 | |||
| Female | 22 | 53.7 | ||||
| Age | 72.32 | 9.48 | 40-91 | |||
| Previousexperience withhearing aids | Yes | 10 | 25.0 | |||
| No | 31 | 75.0 |
Table 5: Study 2 Subjects Demographics and Baseline Characteristics (N=41)
Studv Results
Analysis of within-subject improvement between the two fitting methods revealed that Tuned selffitting demonstrated a higher degree of change in COSI scores (Median = 3.75) compared to professional fitting (Median = 3.50), with z=2.92 and p=.003. Similarly, for IOI-HA scores, Tuned self-fitting exhibited a higher level of improvement (Median = 4.14) compared to professional fitting (Median = 4.00), with a z=2.92 and p=.003. However, no significant difference was observed in COSI 'final ability' between Tuned self-fitting and "professional fitting, median= 4.00), with z=1.19 and p=.233. The results of this analysis are visually presented in Figure 3.
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Image /page/15/Picture/0 description: The image shows the logo for Tuned. The logo consists of a stylized graphic of concentric circles in shades of blue and purple, followed by the word "TUNED" in a simple, sans-serif font. The letters are a dark blue color, and the trademark symbol is located in the upper right corner of the word.
Image /page/15/Figure/1 description: The image is a title for a figure. The title is "Figure 3: Comparison between Professional fitting and Tuned self-fitting in self-reported questionnaires". The title indicates that the figure will compare professional fitting and tuned self-fitting. The data will be from self-reported questionnaires.
Image /page/15/Figure/2 description: The image is a box plot comparing questionnaire scores for tuned self-fitting and professional fitting across different categories. The y-axis represents the questionnaire score, ranging from 1 to 5. The x-axis displays the categories: Tuned self-fitting COSI (degree of change), Professional fitting COSI (degree of change), Tuned self-fitting COSI (final ability), Professional fitting COSI (final ability), Tuned self-fitting IOI-HA, and Professional fitting IOI-HA. Each category has two box plots, one for tuned self-fitting (blue) and one for professional fitting (orange), showing the distribution of questionnaire scores for each fitting method.
The within-subject change analysis based on the initial fitting method revealed that Group 1 participants showed significant improvement in COSI 'degree of change' (Visit 3: Median = 3.12, Visit 5: Median = 4.12, z=3.60, p<.001) and IOI-HA (Visit 3: Median = 3.92, Visit 5: Median = 4.35, z=3.38, p<.001). Marginal significance was found in COSI 'final ability' (Visit 3: Median = 4.37, Visit 5: Median = 4.50, z=1.48, p=.07).
For Group 2, no significant changes were observed in COSI 'degree of change' (Visit 3: Median = 3.75, Visit 5: Median = 3.75, z=-0.16, p=.87), COSI 'final ability' (Visit 3: Median = 4.50, Visit 5: Median = 4.25, z=0.26, p=.79), and IOI-HA (Visit 3: Median = 4.00, Visit 5: Median = 4.00, z=-0.47, p=.64).
Given the above results, there is a potential sequence effect at Visit 5 based on the initial fitting method; however, there was no apparent sequence effect for Visit 3. A sequence effect may interact with the perceived benefit in the subsequent test condition, introducing a limitation in the interpreting the results. However, the subjective self-fitting outcomes were non-inferior to the professional fit condition in both groups (i.e., not poorer), which is clinically acceptable and the overall goal of this study. Finally, given this potential sequence effect occurs only at Visit 5, and not Visit 3, it is possible the above outcomes are not solely driven by a sequence effect.
No adverse events were observed or reported during the course of the study, therefore, no safety analysis was performed.
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Image /page/16/Picture/0 description: The image shows the logo for Tuned. The logo consists of a stylized sound wave icon on the left, followed by the word "TUNED" in a clean, sans-serif font. A trademark symbol is placed to the upper right of the word "TUNED".
Study Conclusion
The clinical data from this study provides evidence of effectiveness of the self-fitting strategy and satisfies the special controls for the self-fitting hearing aids regulation. Participants experienced non-inferior perceptual outcomes and satisfaction with Tuned self-fitting compared to professional fitting.
11. NON-CLINICAL PERFORMANCE TESTING
Non-clinical performance testing was conducted with the Intrisound Tuned Lumen 155 Hearing Aid to provide reasonable assurance of safety and effectiveness as compared to the predicate device, the BHA100 Series Braun® Clear™ Hearing Aid and to support the substantial equivalence determination to the predicate device. A summary of the results are provided in Table 6 below.
| Performance Topic | Applied Standard/Guidance | Results |
|---|---|---|
| Biocompatibility | FDA Guidance “Use of International Standard ISO 10993-1,“Biological evaluation of medical devices -- Part 1: Evaluationand testing within a risk management process” (September2020) | Comply |
| ISO 10993-1:2018, Biological evaluation of medical devices –Part 1: Evaluation and testing within a risk managementprocess | Pass | |
| ISO 10993-5:2009, Biological evaluation of medical devices –Part 5: Tests for in vitro cytotoxicity | Pass | |
| ISO 10993-10:2010, Biological evaluation of medical devices– Part 10: Tests for irritation and skin sensitization | Pass | |
| Basic Safety andEssential Performance | EN 60601-1:2006/A1:2013, Medical electrical equipment –Part 1: General requirements for basic safety and essentialperformance | Pass |
| IEC 60601-1-11:2015, Medical electrical equipment – Part1-11: General requirements for basic safety and essentialperformance — Collateral standard: Requirements formedical electrical equipment and medical electrical systemsused in the home healthcare environment | Pass | |
| EN 60601-2-66:2015, Medical electrical equipment - Part 2-66: Particular requirements for the basic safety and essentialperformance of hearing instruments and hearing instrumentsystems | Pass | |
| ElectromagneticCompatibility | IEC 60601-1-2:2014, Medical electrical equipment – Part 1-2:General requirements for basic safety and essentialperformance - Collateral Standard: Electromagneticdisturbances – Requirements and tests | Pass |
| Acoustic and AudiometricCharacteristics | IEC 60118-13:2019, Electroacoustics - Hearing aids - Part 13:Requirements and methods of measurement forelectromagnetic immunity to mobile digital wireless devices | Pass |
| ANSI ASA S3.22:2014(R2020), Specification of Hearing AidCharacteristics (see Table 2) | Pass |
Table 6: Summary of Non-Clinical Performance Testing
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Image /page/17/Picture/0 description: The image shows the logo for Tuned. The logo consists of a stylized sound wave icon on the left and the word "TUNED" in a sans-serif font on the right. The sound wave icon is made up of concentric arcs in shades of blue and purple. The TM symbol is located to the upper right of the word TUNED.
| Performance Topic | Applied Standard/Guidance | Results |
|---|---|---|
| ANSI CTA 2051:2017, Personal Sound AmplificationPerformance Criteria | Pass | |
| ANSI ASA S3.6:2018 – Specification for Audiometers | Pass | |
| Wireless andCommunication | ANSI C63.19:2019, American National Standard -- Methodsof Measurement of Compatibility Between WirelessCommunications Devices and Hearing Aids | Pass |
| ANSI IEEE C63.27-2017, American National Standard forEvaluation of Wireless Coexistence | Pass | |
| Federal Communications Commission (FCC) Regulation Part15, Low Power, Non-Licensed Transmitter | Pass | |
| AAMI TIR69:2017/(R)2020, Risk Management of Radio-Frequency Wireless Coexistence for Medical Devices andSystems | Comply | |
| Packaging | ISTA Procedure 3A, Packaged-Products for Parcel DeliverySystem Shipment 70 Kg (150 Lb) or Less | Pass |
| Software andCybersecurity | IEC 62304:2006/Amd 1:2015, Medical device software –Software lifecycle processes | Comply |
| FDA guidance "Guidance for the Content of PremarketSubmissions for Software Contained in Medical Devices"(May 2005) | Comply | |
| FDA guidance "Content of Premarket Submissions forManagement of Cybersecurity in Medical Devices" (October2014) | Comply |
Usability Testing
A usability/human factors validation study of the Intrisound™ Tuned Lumen™ 155 Hearing Aid under the authorization and supervision of WCG IRB was conducted in accordance with:
- FDA Guidance "Applying Human Factors and Usability Engineering to Medical Devices" ● (February 2016); and
- IEC 62366-1:2015+A1:2020 Medical devices Part 1: Application of usability engineering . to medical devices.
The study population included 18 untrained subjects with perceived mild to moderate hearing impairment, representing the intended use population.
Each subject was provided with the Intrisound™ Tuned Lumen®155 Hearing Aids, the User Manual, and the Quick-Guide. The study included a series of activities starting with the subject unboxing the hearing aids, followed by downloading and installing the Tuned App, launching and signing-in, pairing the hearing aid and the app, properly fitting the hearing aids on both ears, performing a self-hearing evaluation, and lastly, controlling the volume and changing the programs of the hearing aids through the Tuned App. The subjects were required to perform these activities without any assistance from a hearing care professional and were observed and assessed by the study team comprised of facilitator, audiologist, and developer.
The results of the study confirmed the adequacy of the fitting process of the Intrisound™ Tuned Lumen®155 Hearing Aids and demonstrated that the device can be used safely, effectively and with a high degree of user performance and satisfaction by representative intended users, according to the intended use, and in the intended use environment.
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Image /page/18/Picture/0 description: The image shows the logo for Tuned. The logo consists of a stylized icon resembling sound waves emanating from a central point, followed by the word "TUNED" in a clean, sans-serif font. A small trademark symbol is placed to the upper right of the word "TUNED".
12. SUBSTANTIAL EQUIVALENCE
The Intrisound™ Tuned Lumen® 155 Hearing Aid has the same intended use and as the predicate device, the BHA100 Series Braun™ Clear® Hearing Aid. Like the predicate device, the Intrisound™ Tuned Lumen® 155 Hearing Aid is a user-fitted, wireless, air-conduction hearing aid, intended for over-the-counter use by individuals 18 years or older with perceived mild to moderate hearing impairment.
Clinical and human factors/usability data showed that the effectiveness of the Intrisound™ Tuned Lumen® 155 Hearing Aid was non-inferior to fitting by a licensed audiologist with calibrated clinical audiometer for both self-fitting hearing assessment and user satisfaction and is therefore substantially equivalent to the predicate device in acoustic performance, user satisfaction, and safetv.
Non-clinical performance testing has been conducted to ensure that the device does not raise any new questions of safety and effectiveness as established by the predicate device. Furthermore, device and application firmware and software have been validated per the same standards as used to validate the device and application firmware and software of the predicate device. Results of these verification and validation testing demonstrate that the subject device has substantially equivalent performance to the predicate device.
13. CONCLUSION
The Intrisound™ Tuned Lumen® 155 Hearing Aid has substantially equivalent indications and contraindications, technological characteristics, and performance characteristics as these of the BHA100 Series Braun™ Clear® Hearing Aid predicate device. Any minor differences that exist between the devices are within acceptable margins and/or have been addressed through nonclinical and clinical performance testing. We therefore conclude that Intrisound™ Tuned Lumen® 155 Hearing Aid is as safe and as effective as its predicate device, the BHA100 Series Braun™ Clear® Hearing Aid, without raising any new safety and/or effectiveness concerns and meets the special controls provided in FDA regulation 21 CFR §874.3325.
§ 874.3325 Self-fitting air-conduction hearing aid.
(a)
Identification. A self-fitting air-conduction hearing aid is a wearable sound amplifying device that is intended to compensate for impaired hearing and incorporates technology, including software, that allows users to program their hearing aids. This technology integrates user input with a self-fitting strategy and enables users to independently derive and customize their hearing aid fitting and settings. A self-fitting air-conduction hearing aid is subject to the requirements in § 800.30 or § 801.422 of this chapter, as applicable.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Clinical data must evaluate the effectiveness of the self-fitting strategy.
(2) Electroacoustic parameters, including maximum output limits, distortion levels, self-generated noise levels, latency, and frequency response, must be specified and tested.
(3) Performance data must demonstrate the electromagnetic compatibility (EMC), electrical safety, and thermal safety of the device.
(4) Software verification, validation, and hazard analysis must be performed.
(5) If the device incorporates wireless technology:
(i) Performance testing must validate safety of exposure to non-ionizing radiation; and
(ii) Performance data must validate wireless technology functions.
(6) Usability testing must demonstrate that users can correctly use the device as intended under anticipated conditions of use.