(260 days)
None
No
The description mentions a "proprietary algorithm" for programming the device based on detected auditory thresholds, but there is no mention of AI, ML, or related terms like neural networks or deep learning. The performance studies focus on comparing the self-fitting algorithm's accuracy and subjective outcomes to traditional methods, not on evaluating an AI/ML model's performance.
Yes.
The device is a hearing aid intended to amplify sound for individuals with hearing impairment, which is a therapeutic function.
No
The device is a self-fitting hearing aid intended to amplify sound. While it includes a mobile application that "aims to detect accurate auditory thresholds," this function is described as partnering with the app to deliver user-customized sound through the hearing aid, not primarily to diagnose a medical condition. Its core purpose is sound amplification for perceived hearing impairment, not the diagnosis of hearing loss itself.
No
The device description explicitly mentions hardware components such as a bi-directional microphone, volume and program control, and self-selectable tube and ear tips, in addition to the software application.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections.
- Device Function: The Intrisound™ Tuned Lumen® 155 is a hearing aid. Its function is to amplify sound for individuals with hearing impairment. It works by processing sound from the environment and delivering it to the ear.
- Lack of Biological Sample Analysis: The device does not analyze any biological samples from the user. While it uses a "self-test" through a mobile application to determine auditory thresholds, this is a functional test of hearing, not an analysis of a biological specimen.
Therefore, based on the provided information, the Intrisound™ Tuned Lumen® 155 is a medical device, specifically a hearing aid, but it does not fit the definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
QUH
Device Description
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 fast acting 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.
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
18 years of age or older
Intended User / Care Setting
intended for use without the assistance of a hearing care professional
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)
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
Study 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 MAD 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 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.
Sample Size: 30 adults
Key Results:
- The total MAD of the Tuned self-test and the traditional audiometry performed by a professional averaged for all tested frequencies 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.
- 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 within 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.
- All MPO measurements in the real ear were less than 117 dB SPL, well within the acceptance criterion of
§ 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.
0
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
1
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
2
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 DEVICE
BHA100 Series Braun®
Clear™ Hearing Aid | SUBJECT DEVICE
Intrisound™ Tuned
Lumen® 155
Hearing Aid | Comparison Analysis |
|------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | K212609 | K223848 | NA |
| Product Code | QDD | QUH | The OTC version of the self-
fitting hearing aid has a
different product code (QUH)
than when the predicate device
was originally cleared as a
self-fitting hearing aid. The
only differences relevant to
this change are updated
labeling, design, and
performance characteristics
required by 800.30 for OTC
hearing aids by the enactment
of the OTC Hearing Aid Final
Rule that became effective on
October 17, 2022 |
| Regulation | 21 CFR 874.3325 | 21 CFR 874.3325 | Same |
| Classification
Name | Self-Fitting Air-Conduction
Hearing Aid, Prescription | Self-Fitting Air-Conduction
Hearing Aid, Over The
Counter | - |
| Intended Use | The BHA100 Series Braun®
Clear™ Hearing Aid is a
self-fitting, air conduction
hearing aid, intended to
amplify sound for individuals
18 years of age or older with
perceived mild to moderate
hearing impairment. It is
adjusted by the user to meet
the user's hearing needs. The
device is intended for direct-
to-consumer sale and use
without the assistance of a
hearing health care
professional. | 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 to meet
the user's hearing needs. The
device is intended for use
without the assistance of a
hearing healthcare
professional. | The intended use of the subject
device is similar to the
intended use of the predicate
device with the appropriate
adjustment in accordance with
the OTC Hearing Aid Final
Rule. |
| Device
Description | The BHA100 Series Braun®
Clear™ Hearing Aid is a
self-fitting, air conduction
hearing aid. It features digital
signal processing (16
channel-wide dynamic input
compression, 3 channel fast-
acting output compression,
16 channel noise reduction,
feedback cancellation) | 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 fast-acting output
compression, 16 channel
noise reduction, feedback | The two devices are similar,
with additional equalizer
adjustments in the subject
device, which do not introduce
any new safety or effectiveness
concerns. Performance testing
supports the substantial
equivalence. |
| Characteristic | PREDICATE DEVICE
BHA100 Series Braun®
Clear™ Hearing Aid | SUBJECT DEVICE
Intrisound™ Tuned
Lumen® 155
Hearing Aid | Comparison Analysis |
| | directional microphone with
windscreen, volume and
program control
(environment selection –
Quiet, Noisy, Concert, TV), 3
channel equalizer, self-
adjustable wire and ear tips,
and customization through
the Braun® Clear™ Mobile
Application. The Braun®
ClearCheck™ Hearing Test
aims to detect accurate
auditory thresholds,
partnering with a smart
phone application to deliver
user-customized sound
through the Braun® Clear™
Hearing Aid. These
thresholds are used to
program the device using a
proprietary fitting algorithm. | cancellation), bi-directional
microphone with windscreen,
volume and program control,
12 band equalizer, self-
selectable tube and ear-tip
(dome), 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. | |
| Technology | Wireless, self-fitting air
conduction hearing aid | Wireless, self-fitting air
conduction hearing aid | Same |
| Housing | BTE (Receiver-in-Canal) | BTE (Receiver-in-Aid) | Similar
Both devices are BTE with a
difference being that the
subject device uses the
Receiver-in-Aid assembly
instead of a Receiver-in-Canal
assembly.
Performance testing supports
the substantial equivalence. |
| Power On-Off | Through battery door:
Closed = power ON
Open = power OFF | Through battery door:
Closed = power ON
Open = 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 an
additional ear-tip model.
Performance testing supports
the substantial equivalence |
| Mobile App | Mobile application on a
smartphone with either iOS
or Android platforms. | Mobile application on a
smartphone with either iOS
or Android platforms. | Same |
| Wireless
Communication | Bluetooth protocol | Bluetooth protocol | Same |
| Wireless User
Control Functions | Volume control, program
change selection, settings | Volume control, program
change selection, settings | Same |
| Characteristic | PREDICATE DEVICE
BHA100 Series Braun®
Clear™ Hearing Aid | SUBJECT DEVICE
Intrisound™ Tuned
Lumen® 155
Hearing Aid | Comparison Analysis |
| Bluetooth Pairing
and Control | Pairing and control
verification with the paired
mobile device. | Pairing and control
verification with paired
mobile device. | Same |
| Power Source | Replaceable, disposable, 1.45
Volt, size 312, zinc air
battery | Replaceable, disposable, 1.45
Volt, size 312, zinc air
battery | Same |
| Microphones | Bi-directional microphones
with windscreen | Bi-directional microphones
with windscreen | Same |
| Device Control | On device and through
mobile app | On device and through
mobile app | Same |
| Compression | 16 channel, input controlled,
output limiting | 16 channel, input controlled,
output limiting | Same |
| Noise Reduction | 16 channel | 16 channel | Same |
| Feedback
Cancellation | Adaptive | Adaptive | Same |
| Telephone Calls | None | None | Same |
| Self-Fitting
Method | NAL-NL2 based | NAL-NL2 based propriety
algorithm | Similar.
Performance testing supports
the substantial equivalence. |
| Remote Firmware
Update | None | None | Same |
| Latency | Complies with ANSI CTA
2051-2017 which requires
latency ≤ 15 ms | Complies with (e)(3) of 21
CFR 800.30 and with ANSI
CTA 2051-2017 which
requires latency ≤ 15 ms | Similar.
Performance testing supports
the 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 DEVICE
BHA100 Series Braun®
Clear™ Hearing Aid | SUBJECT DEVICE
Intrisound™ Tuned
Lumen® 155
Hearing 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 supports
the 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 DEVICE
BHA100 Series Braun®
Clear™ Hearing Aid | SUBJECT DEVICE
Intrisound™ Tuned
Lumen® 155
Hearing Aid | Comparison Analysis |
|-----------------------------------------------------|------------------------------------------------------------------------------------------------|------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Max OSPL90 | 120 dB SPL | 114.4 dB SPL | The maximum output of the
subject device is lower than the
predicate device to comply
with the requirements of
21CFR800.30 for OTC hearing
aids.
Performance testing supports
the substantial equivalence. |
| High Frequency
Average OSPL90
(HFA OSPL90) | 111 ± 2 dB SPL | 109.6 ± 2 dB SPL | Both devices meet the
requirements of the standard. |
| High Frequency
Average Full-on
Gain (HFA FOG) | 40 ± 2 dB | 40 ± 2 dB | Both devices meet the
requirements of the standard. |
| Reference Test
Gain (RTG) | 34 ± 4 dB | 34 ± 4 dB | Both devices meet the
requirements of the standard. |
| Frequency
Response | 200 Hz to 8000 Hz | 200 Hz to 8000 Hz | Both devices meet the
requirements of the standard. |
| Frequency Range | 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