(532 days)
The Self-Fitting hearing aids are intended to amplify sound for individuals 18 years of age or older with 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.
Per 21 CFR 874.3325, a self-fitting wireless 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. Self-fitting wireless air conduction hearing aids are Class II medical devices. The Self-Fitting hearing aids incorporate microphones for audio input and sound is delivered to the ear via a receiver that can be coupled with domes. Self-Fitting hearing aids are controlled via button controls and wirelessly via the smart hearing app (iOS and Android). The controls allow the user to adjust volume setting and customize the hearing mode program.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
Acceptance Criteria and Device Performance for Self-Fitting Hearing Aids (K221052)
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Specific Metric | Acceptance Criteria (Non-Inferiority Margin) | Reported Device Performance (Confidence Interval / P-value) |
|---|---|---|---|
| Co-Primary Endpoints | REAG (Self-fit vs. Pro-fit) at 500Hz, 1000Hz, 2000Hz, 4000Hz (Lab) | -2.5 dB (non-inferiority margin) | - Right Ear: 500Hz: (-1.7976, 0.8933), P<0.0001 1000Hz: (-2.6485, 1.0217), P=0.0005 (Note: Upper bound for 1000Hz is slightly above 2.5, but text states "less than the threshold of 2.5" - this might be due to rounding or a specific interpretation of the non-inferiority test, which relies on the lower bound being above the margin for superiority. The p-value indicates non-inferiority was met.) 2000Hz: (-1.0099, 1.0003), P=<0.0001 4000Hz: (-1.6803, 2.2401), P=0.0139- Left Ear: 500Hz: (-2.4308, 0.5744), P=<0.0001 1000Hz: (-3.9191, 0.6464), P=0.0009 2000Hz: (-4.3019, -0.6981), P=<0.0001 (Negative lower bound suggests superiority of self-fit, still meets non-inferiority) 4000Hz: (-2.3433, 2.3625), P=0.0194Conclusion: Laboratory REAG of Self-fit condition was not inferior to Pro-fit condition with a threshold of 2.5 dB. |
| REAG (Self-fit1 vs. Self-fit2) at 500Hz, 1000Hz, 2000Hz, 4000Hz (Lab) | Similar (statistical non-significance) | - Right Ear: 500Hz: (-1.0725, 0.8725), P=0.8349 1000Hz: (-0.6767, 1.9434), P=0.3310 2000Hz: (-1.9115, 1.1115), P=0.5925 4000Hz: (-1.1188, 1.8522), P=0.6175 - Left Ear: 500Hz: (-1.5968, 1.3302), P=0.8535 1000Hz: (-0.5968, 2.3302), P=0.2356 2000Hz: (-0.4443, 2.1777), P=0.1868 4000Hz: (-1.8498, 1.9831), P=0.9438 Conclusion: No statistically significant difference between the two measurements of REAG for Self-fit repeated measures in the laboratory, indicating similarity. | |
| APHAB global rating (Self-fit vs. Pro-fit) (Field Trial) | -0.084 (non-inferiority margin) | Point estimate = 0.0109 (95% CI: -0.00951, 0.0314). All values in the CI are greater than the non-inferiority margin of -0.084. P<0.0001.Conclusion: During the on-site field trial, APHAB global ratings in the Self-fit condition were not inferior to those of the Pro-fit condition with the non-inferiority margin of 0.084. | |
| Secondary Endpoints | SNR (Self-fit vs. Pro-fit) (Lab) | Not inferior (no specific margin given) | Difference = 0.4450 (95% CI: -0.6703, 1.5602) |
| SNR (Self-fit1 vs. Self-fit2) (Lab) | Similar (statistical non-significance) | Difference = 0.4000 (95% CI: -0.5020, 1.3020) | |
| SNR (Self-fit vs. Pro-fit) (Field Trial) | Not inferior (no specific margin given) | Difference = -0.1830 (95% CI: -1.0473, 0.6812) | |
| Safety Evaluation | Absence of device-related Adverse Events (AE) or Serious Adverse Events (SAE) | No AEs or SAEs reported | All participants were free from ear infections, pain/discomfort, dizziness, and sudden onset/rapid deterioration of tinnitus. No adverse events were reported during the clinical trial. |
2. Sample Sizes and Data Provenance:
- Clinical Test Set Sample Size: 36 subjects were initially enrolled, but 6 withdrew, resulting in 30 subjects for analysis. The document states the planned minimum was 32 subjects.
- Data Provenance: The clinical study was a prospective, randomized, cross-assigned, non-inferiority, multi-center clinical trial. The locations of the two on-site centers are implied to be within the country of the submitter (China, Huizhou Jinghao Medical Technology Co., Ltd. and Shenzhen Reanny Medical Devices Management Consulting Co., Ltd.), though not explicitly stated for the subjects' origin.
3. Number and Qualifications of Experts for Ground Truth:
- For the Pro-fit condition, which serves as a comparison to the self-fit device, the text refers to "audiological best practice hearing aid fittings." This implies that qualified audiologists or hearing care professionals established the "ground truth" for the professional fitting. The number and specific qualifications of these experts are not explicitly stated in the provided text.
4. Adjudication Method for the Test Set:
- The study design was a randomized, cross-assigned, non-inferiority, multi-center clinical trial. Participants underwent two stages: "laboratory" and "on-site cross wear field trial."
- Within the laboratory stage, participants completed "Self-fit1", "Self-fit2", and "Pro-fit" procedures in random order.
- The field trial involved a crossover design with participants receiving "Pro-fit" and "Self-fit" in random order.
- This design inherently compares the different fitting strategies rather than relying on a separate adjudication method for individual cases or outcomes from human readers. The outcomes (REAG, APHAB, SNR) are objective measurements or standardized questionnaires, directly comparing the performance of the self-fitted device to a professionally fitted one. No specific adjudication method like 2+1 or 3+1 is mentioned, as it's not a study involving human reader interpretations that need consensus.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted in the traditional sense for image interpretation. This study focuses on the comparison between a self-fitting hearing aid and a professionally-fitted hearing aid, not on the performance of human readers with or without AI assistance for interpretation. Therefore, there is no effect size of how much human readers improve with AI vs. without AI assistance.
6. Standalone (Algorithm Only) Performance Study:
- Yes, a standalone performance study was conducted in the sense that the "Self-fit" condition represents the algorithm's performance without direct intervention from a hearing care professional during the fitting process by the user. The co-primary and secondary endpoints directly measure the performance of this self-fitting strategy against a professional fitting.
7. Type of Ground Truth Used:
- For the clinical study, the "ground truth" or reference for comparison was established by:
- Audiological Best Practice Hearing Aid Fittings (Pro-fit): This involved a professionally conducted fitting, likely by qualified audiologists, measuring Real Ear Aided Gain (REAG) and collecting data on Abbreviated Profile of Hearing Aid Benefit (APHAB) and Speech Recognition Threshold in Noise (SNR). This serves as the "gold standard" or "expert ground truth" for optimal hearing aid performance.
- Repeated Self-fitting Measurements (Self-fit1 vs. Self-fit2): This evaluated the consistency and repeatability of the device's self-fitting process, essentially using the device's own repeated output as a comparison for its internal consistency.
8. Sample Size for the Training Set:
- The document describes a clinical validation study for effectiveness and safety. It does not explicitly mention a training set sample size for the development of the self-fitting algorithm itself. The clinical study is a test set of real users validating the already developed self-fitting strategy.
9. How Ground Truth for the Training Set Was Established:
- Since there's no explicit mention of a training set or its sample size, there's no information provided on how ground truth for a training set was established. The self-fitting strategy is a feature of the device; its development would likely involve internal testing, algorithm design, and potentially proprietary data, but these details are not part of this 510(k) summary which focuses on the clinical validation of the final product.
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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
September 25, 2023
Huizhou Jinghao Medical Technology Co., Ltd. % Reanny Wang General Manager Shenzhen Reanny Medical Devices Management Consulting Co Ltd Room 1407, Jingting Building, Dongzhou Community, Guangming Street, Guangming District Shenzhen, Guangdong 518000 China
Re: K221052
Trade/Device Name: Self-Fitting 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 21, 2023 Received: August 25, 2023
Dear Reanny Wang:
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/cdrl/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
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statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801): medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531 -542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
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 Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K221052
Device Name Self-Fitting hearing aid
Indications for Use (Describe)
The Self-Fitting hearing aids are intended to amplify sound for individuals 18 years of age or older with 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.
| Type of Use (Select one or both, as applicable) | Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) | Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | |||
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary
The assigned 510(k) number is:_________________K221052
1.0 Information of Submitter and Correspondent
Submitter's information:
Company Name: Huizhou Jinghao Medical Technology CO., LTD.
Floor 6, Huicheng Industry Building,No.9 Huifeng Dong'er Road Zhongkai High- Tech Address: Zone Huizhou City, Guangdong Province, China
Telephone: +86(752)-2266961
Contact Person: Yuanxia Mao
Contact Title: Management representative
Contact Email: maoyuanxia@jinghao.info
Submission correspondent information:
Company Name: Shenzhen Reanny Medical Devices Management Consulting Co., Ltd
Address: Room 1407, Jingting Building, Dongzhou Community, Guangming Street, Guangming District, Shenzhen, Guangdong Province, China
- Contact person: Reanny Wanq
E-Mail: Reanny@reanny.com
2.0 510(k) Summary prepared date
September 1, 2023
3.0 Device Information
Trade Name: Self-Fitting hearing aid Models: JH-D58 Common Name: Hearing aids Classification Name: Self-Fitting Air-Conduction Hearing Aid Requlation Description: Self-Fitting Air-Conduction Hearing Aid Regulation Medical Specialty: Ear Nose & Throat Product Code: QUH Regulation Number: 21 CFR 874.3325 Device Class: 2
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4.0 Predicate Device Information
Predicate device:
| Sponsor: | Bose Corporation |
|---|---|
| Device: | Bose SoundControl Hearing Aids |
| 510(K) Number: | K211008 |
| Reference device: | |
| Sponsor: | Kaz USA, Inc., a Helen of Troy Company |
| Device: | BHA100 Series Braun Clear Hearing Aid |
| 510(K) Number: | K212609 |
5.0 Intended Use/Indications for use
The Self-Fitting hearing aids are 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 care professional.
6.0 Device Information
Per 21 CFR 874.3325, a self-fitting wireless 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. Self-fitting wireless air conduction hearing aids are Class II medical devices. The Self-Fitting hearing aids incorporate microphones for audio input and sound is delivered to the ear via a receiver that can be coupled with domes. Self-Fitting hearing aids are controlled via button controls and wirelessly via the smart hearing app (iOS and Android). The controls allow the user to adjust volume setting and customize the hearing mode program.
7.0 Labeling
The Self-Fitting hearing aid user manual including the following elements:
- Manufacturer Information
- Intended Use/Indications for use
- Directions for Use, including hearing aid and APP's operation
- Warnings and Precautions
- Specifications
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The labeling is compliant with 21 CFR 800.30 (c) for OTC hearing aids, which includes information to help the user identify if they are a candidate for this device.
8.0 Special controls
The Self-Fitting Hearing Aid conforms to the special controls stated in 21 CFR 874.3325. These requirements were satisfied through the following:
- Clinical Validation
- Non-Clinical Performance Testing
- Usability Validation
- Labeling
9.0 Performance Summary
Performance data includes "Non-Clinical Data" and "Clinical Data", as described below.
9.1 Non-Clinical Testing:
The following performance data were provided in support of the substantial equivalence determination.
Biocompatibility testing
The biocompatibility evaluation for the Self-Fitting hearing aids was conducted in accordance with the International Standard ISO 10993-1 "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing within a Risk Management Process," for an intact skin contacting device. The following tests were performed, and results demonstrate the biocompatibility of the subject device: Cytotoxicity, Skin Sensitization, Skin Irritation.
Electrical safety, Home Healthcare environment and electromagnetic compatibility (EMC)
Electrical safety, Home Healthcare environment and EMC testing were conducted, and the results show that the subject device complies with the IEC 60601-1: 2005+CORR. 1 (2006)+CORR. 2 (2007)+A1: 2012 Medical electrical equipment Part 1: General requirements for basic safety and essential performance, IEC 60601-1-11: 2015 Medical electrical equipment -Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment, and the IEC 60601-1-2: 2014 Medical electrical equipment –Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests.
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Bench Testing
Bench testing was conducted, and the results show that the subject device complies with the IEC 60601-2-66:2019 Medical electrical equipment – Part 2-66: Particular requirements for the basic safety and essential performance of hearing aids and hearing aid systems and ANSI ASA S3.22-2014 American National Standard Specification of Hearing Aid Characteristics. The performance meets the requirements defined in IEC 60601-2-66 and ANSI ASA S3.22. The subject device also conforms to the applicable clauses of ANSI ASA S3.6: Specifications for Audiometers, similar to the BHA100 Series Braun® Clear™ Hearing Aid reference device.
Software Verification and Validation Testing
Software documentation including verification & validation was provided in accordance with FDA Guidance: Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices for software with a moderate level of concern.
Usability testing
The usability test included 20 untrained participants representing the intended user population (individuals 18 year of age or older with perceived mild to moderate hearing impairment), each of whom performed hands-on use scenarios and knowledge tasks with the Self-Fitting hearing aids, including the "JH Smart" APP, accessories, and user documentation including the labels and user manual. After the use scenarios and knowledge tasks, the participants completed subjective questionnaires about their use of the device. Results indicated that the Self-Fitting hearing aids are able to be used correctly by the intended users under anticipated conditions of use.
9.2 Clinical Testing:
Clinical design and procedure:
A clinical study was conducted to verify the safety and effectiveness of the Self-fitting hearing aids (model JH-D58) and "JH Smart" APP in users with mild to moderate hearing impairment. This study was a prospective, randomized, cross-assigned, non-inferiority, multi-center clinical trial.
This study had two stages: laboratory and on-site cross wear field trial.
During the laboratory stage, participants completed in random order, the first self-adaptation (Self-fit1) and second self-adaptation (Self-fit2) procedures according to the instructions in the User Manual, and audiological best practice hearing aid fittings (Pro-fit).
During the field trial stage, a crossover design was used with each participant receiving two fitting strategies in random order (Pro-fit and Self-fit). Each wear cycle lasted 10-14 days. A flow chart of the two stages is shown below:
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Image /page/7/Figure/0 description: The image shows a diagram of six different sequences (Seq 1-6) that are divided into two stages: "Lab stage (Visit 1)" and "On-site cross wear stage (Visit 2, Visit 3)". Each sequence consists of three steps in the lab stage and two steps in the on-site stage. The steps are labeled as either "Self-fit" or "Pro-fit", and the order of these steps varies across the six sequences.
Sample size and subjects:
The sample size for this clinical study was determined by the main outcome measurement value, Abbreviated Profile of Hearing Aid Benefit (APHAB), of the field trial. The sample size estimation software is based on PASS 15.0 and requires a total of 32 samples, which means that the sample size for each sequence group in the crossover design stage is 16.
36 subjects who met the inclusion criteria were selected as the research subjects, and the study was conducted at two on-site centers (18 subjects per center). The study population is described in the table below:
| Variables | Value | Total(n=36) | Self-Pro group | Pro-Self group | Chi-square | P-value |
|---|---|---|---|---|---|---|
| Age group | 18~40 | 4(11.1) | 2(11.1) | 2(11.1) | - | 0.594 |
| 41~50 | 2(5.6) | 2(11.1) | 0(0.0) | |||
| 51~60 | 9(25.0) | 3(16.7) | 6(33.3) | |||
| 61~70 | 13(36.1) | 6(33.3) | 7(38.9) | |||
| ≥71 | 8(22.2) | 5(27.8) | 3(16.7) | |||
| Gender | Female | 17(47.2) | 11(61.1) | 6(33.3) | 2.786 | 0.095 |
| Male | 19(52.8) | 7(38.9) | 12(66.7) | |||
| History of hearing aiduse | No | 36(100.0) | 18(100.0) | 18(100.0) | 0.000 | 1.000 |
Of the 36 subjects enrolled, 6 subjects withdrew due to poor compliance or personal reasons. This study was ultimately based on 30 subjects for analysis. Although the sample size of this clinical study did not reach the planned minimum of 32 subjects (due to subject withdrawal), the results from the remaining 30 subjects still demonstrate the effectiveness of the self-fitting strategy, albeit with slightly reduced statistical power.
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Effectiveness analysis endpoints:
-
- Co-Primary Endpoints:
- a) In the first stage of laboratory wearing, the Real Ear Aided Gain (REAG) in the Self-fit condition at four frequencies (500Hz, 1000Hz, 2000Hz, 4000Hz) in the left and right ears was not inferior to that in the Pro-fit condition with a non-inferiority margin of 2.5 dB.
- b) In the first stage of laboratory wearing, REAG (Self-fit 1 vs Self-fit 2) measurements were similar between the two Self-fit measurements.
- c) In the second stage of field trial wearing, the APHAB global rating of the Self-fit condition is not inferior to that of the Pro-fit condition with a non-inferiority margin of 0.084.
-
- Secondary Endpoints:
- a) In the first stage of laboratory wearing, the speech recognition threshold in noise (SNR) in the Self-fit condition is not inferior to that of the Pro-fit condition.
- b) In the first stage of laboratory wearing, the speech recognition threshold in noise (Self-fit1 vs Self-fit2) is similar, and the results of the two Self-fit measurements are similar.
- c) In the second stage of field trial wearing, the speech recognition threshold in noise (Self-fit vs. Pro-fit), of the Self-fit condition is not inferior to that of the Pro-fit condition.
Safety Evaluation:
Record adverse events (AE) or serious adverse events (SAE) related to the test device.
Results:
Co-Primary Effectiveness Endpoints:
-
- First co-primary endpoint: In the laboratory, the REAG (Self-fit1 vs Pro-fit) at four frequencies (500Hz, 1000Hz, 2000Hz, 4000Hz)
Analysis results: The analysis of variance results of the 2x2 cross design showed that the estimated points of the difference in REAG between the two fitting conditions were between -2.5000 and 0.2799 at each frequency of the left and right ears. The 95% confidence intervals for the difference between the right ear conditions at 500Hz, 1000Hz, and 4000Hz are (-1.7976,0.8933), (-2.6485,1.0217), (-1.0099,1.0003), (-1.6803,2.2401); the 95% confidence intervals for the difference between the left ear conditions at 500Hz, 1000Hz, 2000Hz, and 4000Hz are (-2.4308, 0.5744), (-3.9191, 0.6464), (-4.3019, -0.6981), (-2.3433, 2.3625). The non-inferiority margin of 2.5 and the upper limit of 95% confidence interval Page 6 of 14
- First co-primary endpoint: In the laboratory, the REAG (Self-fit1 vs Pro-fit) at four frequencies (500Hz, 1000Hz, 2000Hz, 4000Hz)
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between all parts and frequencies is less than the threshold of 2.5; The P values for the noninferiority test between the two fitting conditions at different frequencies 500Hz, 1000Hz, 2000Hz, and 4000Hz in the left and right ears are: Right ear: P<0.0001, P=0.0005, P=<0.0001, P=0.0139; Left ear: P=<0.0001, P=0.0009, P=<0.0001, P=0.0194.
Figure 1 (below) shows the real-ear aided gain (REAG) for both fitting conditions (Self-fit and Pro-fit) across the frequency range (n = 30 subjects). Figure 1 shows that the two test conditions have similar REAG results.
Image /page/9/Figure/2 description: The image is a plot that shows REAG on the y-axis and Frequency(Hz) on the x-axis. The plot contains two groups, Pro and Self, which are represented by blue and red colors, respectively. The plot shows that REAG increases with frequency for both groups. At 500 Hz, REAG is around 5 for both groups, while at 4000 Hz, REAG is around 25 for both groups.
Figure 1: Error bar chart of REAG at 500, 1000, 2000, and 4000 Hz (mean ± standard deviation) for the Self-fit and Pro-fit conditions.
Conclusion: At the four frequencies (500Hz, 1000Hz, 2000Hz, 4000Hz) of the left and right ears, the laboratory REAG of the Self-fit condition was not inferior to the Pro-fit condition with a threshold of 2.5 dB.
-
- Second co-primary endpoint: In the laboratory, REAG (Self-fit1 vs Self-fit2) measurements
Analysis results: The paired t-test results showed that at each frequency of the left and right ears, the estimated point difference between the two measurements of the Self-fit condition (Self-fit1-Self-fit2) REAG was between -0.4000 and 0.8667. The 95% confidence intervals for the difference between the two measurements of 500Hz, 2000Hz, and 4000Hz in the right ear were (-1.0725,0.8725), (-0.6767,1.9434), (-1.9115,1.1115), (-1.1188,1.8522); the 95% confidence intervals for the difference between the two measurements of 500Hz, 1000Hz, 2000Hz, and 4000Hz in the left ear were (-1.5968, 1.3302), (-0.5968, 2.3302), (-0.4443, 2.1777), (-1.8498, 1.9831). The test statistics and P-values are shown in the table below:
- Second co-primary endpoint: In the laboratory, REAG (Self-fit1 vs Self-fit2) measurements
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| Site | Frequency | Mean | Standarddeviation | 95% lower limit | 95% upper limit | t value | P value |
|---|---|---|---|---|---|---|---|
| Rightear | 500 | -0.1000 | 2.6044 | -1.0725 | 0.8725 | -0.21 | 0.8349 |
| Rightear | 1000 | 0.6333 | 3.5084 | -0.6767 | 1.9434 | 0.99 | 0.3310 |
| Rightear | 2000 | -0.4000 | 4.0480 | -1.9115 | 1.1115 | -0.54 | 0.5925 |
| Rightear | 4000 | 0.3667 | 3.9782 | -1.1188 | 1.8522 | 0.50 | 0.6175 |
| Left ear | 500 | -0.1333 | 3.9193 | -1.5968 | 1.3302 | -0.19 | 0.8535 |
| Left ear | 1000 | 0.8667 | 3.9193 | -0.5968 | 2.3302 | 1.21 | 0.2356 |
| Left ear | 2000 | 0.8667 | 3.5109 | -0.4443 | 2.1777 | 1.35 | 0.1868 |
| Left ear | 4000 | 0.0667 | 5.1323 | -1.8498 | 1.9831 | 0.07 | 0.9438 |
Conclusion: At the four frequencies (500Hz, 1000Hz, 2000Hz, 4000Hz) of the left and right ears, there was no statistically significant difference between the two measurements of the REAG for the Self-fit repeated measures in the laboratory, and the results of the two Self-fit measurements were similar.
3. Third co-primary endpoint: APHAB global rating (field trial)
Analysis results: The analysis of variance results of the 2x2 cross design showed that the point estimate of the APHAB difference between the two device groups in the on-site cross wearing test was 0.0109 (95%Cl: -0.00951,0.0314). Using 0.084 as the non-inferiority threshold for non-inferiority testing, the 95% confidence interval (-0.00951~0.0314) of the difference between the global APHAB scores of the two devices was lower than the threshold value of 0.084 (P<0.0001).
Conclusion: During the on-site field trial, APHAB global ratings in the Self-fit condition were not inferior to those of the Pro-fit condition with the non-inferiority margin of 0.084.
Secondary Effectiveness Endpoints:
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- In-lab speech reception threshold in noise SNR (Pro-fit vs Self-fit1): The analysis of variance results of the 2x2 cross design showed that after considering stage effects, the difference in SNR between the two fitting conditions was 0.4450 (95%Cl: -0.6703, 1.5602). The correlation coefficients of speech recognition thresholds between the Self-fit1-Pro-fit condition and the Pro-fit-Self-fit1 condition were 0.83519 and 0.94816, respectively.
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- In-lab speech reception threshold in noise SNR (Self-fit1 vs Self-fit2): The paired t-test analysis results showed that the difference between the two Self-fit measurements was Page 8 of 14
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0.4000 (95%Cl: -0.5020, 1.3020). The correlation coefficient between the two measurements of speech recognition threshold was 0.91817.
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- On-site field trial speech reception threshold in noise SNR (Pro-fit vs Self-fit); The analysis of variance results of the 2x2 cross design showed that after considering stage effects, the difference in SNR between the two fitting conditions was -0.1830(95%Cl: -1.0473, 0.6812). The correlation coefficients between the speech recognition thresholds of the Selffit1-Pro-fit condition and the Pro-fit-Self-fit1 condition were 0.92112, 0.92365, respectively.
The confidence intervals for the secondary endpoints are at their nominal level without adjusting for the multiplicity issue.
- On-site field trial speech reception threshold in noise SNR (Pro-fit vs Self-fit); The analysis of variance results of the 2x2 cross design showed that after considering stage effects, the difference in SNR between the two fitting conditions was -0.1830(95%Cl: -1.0473, 0.6812). The correlation coefficients between the speech recognition thresholds of the Selffit1-Pro-fit condition and the Pro-fit-Self-fit1 condition were 0.92112, 0.92365, respectively.
Safety Evaluation:
All participants were free from ear infections, pain or discomfort, acute or chronic dizziness, and no sudden onset or rapid deterioration of tinnitus in one or both ears during baseline screening and wearing hearing aids. No adverse events were reported during the clinical trial.
Study Conclusions
The clinical data from this study demonstrates the effectiveness of the self-fitting strategy and satisfies the special controls for the self-fitting hearing aids regulation. Participants experienced non-inferior outcomes with self-fitting compared to professional fitting of the subject device.
10.0 Comparison to predicate device
The subject device Self-Fitting hearing aid has similar indications for use and technological characteristics as the predicate device Bose SoundControl Hearing Aids (K211008) and reference device BHA100 Series Braun Clear Hearing Aid (K212609). They are all self-fitting hearing aids indicated for individuals 18 and older with perceived mild to moderate hearing impairment. The same fundamental technology is present in these three hearing aids to allow the user to control and customize the device to the user's hearing needs. The table below provides an overview comparison of the subject, predicate, and reference devices:
| Elements ofComparison | Predicate Device(K211008) | Reference Device(K212609) | Subject Device | Comparison |
|---|---|---|---|---|
| Models | BMD0012 | BHA100 series | JH-D58 | -- |
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| Company | Bose Corporation | Kaz USA, Inc., a Helenof Troy Company | Huizhou Jinghao MedicalTechnology Co., Ltd. | -- | OSPL90Curve | Image: OSPL90 Curve | Image: OSPL90 Curve | Image: OSPL90 Curve | Performance testing wasconducted to evaluatedifferences in technologyand the results supportsubstantial equivalence. |
|---|---|---|---|---|---|---|---|---|---|
| DeviceName | Bose SoundControlHearing Aids | BHA100 Series BraunClear Hearing Aid | Self-Fitting Hearing Aid | -- | MaxOSPL90 | 113 dBSPL | 120 dBSPL | 117dBSPL | Performance testing wasconducted to evaluatedifferences in technologyand the results supportsubstantial equivalence.The Max output does notexceed 117dB SPL at anyfrequency and is thereforecompliant with 21CFR800.30requirements for OTC hearingaids. |
| Productcode | QDD | QDD | QUH | The OTC version of theself-fitting hearing aid hasa different product code(QUH) than when thepredicate device wasoriginally cleared as a self-fitting hearing aid. The onlydifferences relevant to thischange are updatedlabeling, design, andperformancecharacteristics required by21 CFR 800.30 for OTChearing aids. | HFAOSPL90 | 106 dBSPL | $111\pm2$ dBSPL | $<108dB\pm4dB$ | Performance testing wasconducted to evaluatedifferences in technologyand the results supportsubstantial equivalence. |
| Regulation # | 21CFR874.3325 | 21 CFR 874.3325 | 21CFR874.3325 | Same | HFA FOG | 30 dB | $40\pm2$ dB | $<35dB\pm5dB$ | Performance testing wasconducted to evaluatedifferences in technologyand the results supportsubstantial equivalence. |
| Intended use | The BoseSoundControlTMHearing Aids isintended to amplifysound for individuals18 years of age orolder with perceivedmild to moderatehearing impairment. Itis adjusted by the userto meet the user'shearing needs. Nopreprogramming orhearing test isnecessary. The deviceis intended for direct-to- consumer sale anduse without theassistance of ahearing careprofessional. | The BHA100 SeriesBraun® ClearTMHearing Aid is a self-fitting, air conductionhearing aid, intended toamplify sound forindividuals 18 years ofage or older withperceived mild tomoderate hearingimpairment. It isadjusted by the user tomeet the user'shearing needs.The device is intendedfor direct-to-consumersale and use withoutthe assistance of ahearinghealth care professional. | The Self-Fitting hearingaids are intended toamplify sound forindividuals 18 years ofage or older withperceived mild tomoderate hearingimpairment. They areadjusted by the user tomeet the user's hearingneeds. The device isintended for use withoutthe assistance of ahearing careprofessional. | The intended use of thesubject device is similar tothe intended use of thepredicate device with theappropriate adjustment inaccordance with the OTCHearing Aid Final Rule. | RTG | 29 dB | 34+/-4 dB | 33 dB | Performance testing wasconducted to evaluatedifferences in technologyand the results supportsubstantial equivalence. |
| Type | BTE | BTE | BTE | Same | Frequencyrange | <200-8000 Hz | 200 Hz to 8000 Hz | 250~5000Hz (Notnarrower than) | Performance testing wasconducted to evaluatedifferences in technologyand the results supportsubstantial equivalence.The frequency range is atleast 250-5000Hz and istherefore compliant with21CFR800.30 requirementsfor OTC hearing aids. |
| PatientPopulation | 18 years and older | 18 years and older | 18 years and older | Same | |||||
| Soundmode | Air conduction | Air conduction | Air conduction | Same |
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| HarmonicDistortion | <1% | 500 Hz ≤ 1.5%800 Hz ≤ 2.0%600 Hz ≤ 3.0% | < 0.4%+3% | The distortion does notexceed 5% and is thereforecompliant with 21CFR800.30requirements for OTChearing aids. | • RIC style hearing aid• A Replaceable Battery | Compatibility(iOS, Android)• Replaceable,Disposable, 1.45Volt, Size 312,Zinc Air HearingAid Battery• Traditional, Receiver-In- Canal (RIC) /Behind- The-Ear(BTE) Form Factor• Self-administeredhearing test | • Rechargeable Li-ionbattery• Traditional, Receiver-In-Canal (RIC) / Behind-The-Ear (BTE) FormFactor• Self-administeredhearing test | |||
|---|---|---|---|---|---|---|---|---|---|---|
| EIN | <27 dBSPL | <29dB SPL | ≤ 32dBSPL | Performance testing wasconducted to evaluatedifferences in technologyand the results supportsubstantial equivalence.The EIN does not exceed32dB and is thereforecompliant with 21CFR800.30requirements for OTC hearingaids. | Degree ofprotectionagainstelectricshock | Type B applied part | Unknown | Type B applied part | Same | |
| Attack Time | -- | -- | 700ms ±50% | -- | Type ofprotectionagainstelectricshock | Internally powerequipment | Internally powerequipment | Internally powerequipment | Same | |
| Release Time | -- | -- | 700ms ±50% | -- | Model ofOperation | Continuous operation | Continuous operation | Continuous operation | Same | |
| Latency | -- | -- | ≤ 14ms | The latency does not exceed15ms and is thereforecompliant with 21CFR800.30requirements for OTChearing aids. | Compliance withCompliance IEC 60601-2-66:2019ANSI/ASA S3.22 2014ANSI CTA 2051:2017 | Compliance withCompliance IEC 60601-2-66:2019ANSI/ASA S3.22 2014ANSI CTA 2051:2017 | ||||
| Batterycurrent drain | 2.8mA | 2.5mA | < 10mA | Performance testing wasconducted to evaluatedifferences in technologyand the results supportsubstantial equivalence. | Performance | Compliance withCompliance with IEC60601-2-66:2019ANSI/ASA S3.22 2014 | Same | |||
| Powersupply | DC 1.45V, Size 312Battery | DC 1.45V, #312 zinc airbatteries | DC 3.7V / 45mAhRechargeable Li-ionbattery | Performance testing wasconducted to evaluatedifferences in technologyand the results supportsubstantial equivalence. | Safety | Compliance withCompliance with IEC60601- 1:2005+A1:2012IEC 60601-1-11:2015IEC 60601-1-2:2014 | CompliancewithCompliancewith IEC60601- 1:2005+A1:2012IEC 60601-1-11:2015IEC 60601-1-2:2014 | Compliance withCompliance withIEC 60601-1:2005+A1:2012IEC 60601-1-11:2015IEC 60601-1-2:2014 | Same | |
| Technologicalcharacteristics | • Self-Fitting Hearing Aid• Home HealthcareEnvironment Use• Bluetooth• On Device Controls• App (Bose Hear app)• Software PlatformCompatibility (iOS,Android) | • Self-Fitting Hearing Aid• Home HealthcareEnvironment Use• Bluetooth• On Device Controls• App (Braun® Clear™App)• SoftwarePlatform | • Self-Fitting Hearing Aid• Home HealthcareEnvironment Use• Bluetooth• On Device Controls• App (JH Smart APP)• Software PlatformCompatibility(iOS, Android) | Performance testing wasconducted to evaluatedifferences in technologyand the results supportsubstantial equivalence. | ||||||
| Material | ABS housing andABS keys | ABS housing and ABSkeys | ABS housing andABS keys | Same |
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| Biocompatibility | All the patient contacting materials are compliance with ISO 10993 | All the patient contacting materials are compliance with ISO 10993 | All the patient contacting materials are compliance with ISO 10993 | Same |
|---|---|---|---|---|
| ------------------ | -------------------------------------------------------------------- | -------------------------------------------------------------------- | -------------------------------------------------------------------- | ------ |
As seen in the comparison tables, the subject and predicate devices have same design principle, similar design features and performance specifications. The different technological characteristics between the subject and predicate devices do not raise different questions of safety or effectiveness. The subject and predicate devices have some relatively minor differences in their electroacoustic characteristics (e.g., MaxOSPL90, HFA FOG) and a different battery type; however, clinical testing demonstrated reasonably safe and effective outcomes that are appropriate for the intended use population, similar to the predicate device.
11.0 Conclusion
The Self-Fitting hearing aid is intended to amplify sound for individuals 18 years of age or older with perceived mild to moderate hearing impairment without the assistance of a hearing care professional. The Self-Fitting hearing aid has similar indications, technological characteristics, and performance characteristics as the Bose SoundControl predicate device. Non-clinical testing and clinical testing were conducted on the subject device and all testing passed pre-specified criteria. Any minor differences between the subject and predicate devices have been addressed through the performance testing. The risks of the Self-Fitting hearing aid also have been evaluated according to ISO 14971, and the overall residual risk are acceptable. In conclusion, the subject device is as safe and effective, and performs as well as, the legally marketed predicate device predicate. The Self-Fitting hearing aid meets the special controls for self-fitting hearing aids outlined in 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.