(532 days)
No
The summary describes a "self-fitting strategy" that integrates user input, but it does not explicitly mention or provide details about the use of AI or ML algorithms for this self-fitting process. The performance studies focus on traditional hearing aid metrics and comparisons to predicate devices, without mentioning AI/ML-specific evaluation metrics or training/test data characteristics typically associated with AI/ML devices.
Yes
The device is intended to compensate for impaired hearing by amplifying sound.
No
The device is intended to amplify sound for individuals with hearing impairment. It is a self-fitting hearing aid and performs no diagnostic function.
No
The device description explicitly states that the device incorporates microphones and a receiver for sound delivery, which are hardware components. While it includes software for self-fitting, it is not solely software.
Based on the provided information, 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, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states that this device is a "wearable sound amplifying device that is intended to compensate for impaired hearing." It works by amplifying sound and delivering it to the ear.
- Lack of Biological Sample Analysis: There is no mention of the device analyzing any biological samples from the user. Its function is purely related to processing and amplifying external sound.
- Intended Use: The intended use is to amplify sound for individuals with hearing impairment, not to diagnose or detect a disease or condition through the analysis of biological samples.
Therefore, this device falls under the category of a hearing aid, which is a medical device but not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
QUH
Device Description
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.
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
individuals ... 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
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:
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).
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.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance Summary
Performance data includes "Non-Clinical Data" and "Clinical Data", as described below.
Non-Clinical Testing:
- Biocompatibility testing
- Electrical safety, Home Healthcare environment and electromagnetic compatibility (EMC)
- Bench Testing
- Software Verification and Validation Testing
- Usability testing
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.
Sample size and subjects:
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). 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.
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 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
- First co-primary endpoint: In the laboratory, the REAG (Self-fit1 vs Pro-fit) at four frequencies (500Hz, 1000Hz, 2000Hz, 4000Hz)
§ 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.
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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
1
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
2
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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3
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
4
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
5
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.
6
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:
7
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 | 1840 | 4(11.1) | 2(11.1) | 2(11.1) | - | 0.594 |50 | 2(5.6) | 2(11.1) | 0(0.0) | | |
| | 41
| | 5160 | 9(25.0) | 3(16.7) | 6(33.3) | | |70 | 13(36.1) | 6(33.3) | 7(38.9) | | |
| | 61
| | ≥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 aid
use | 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.
8
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)
9
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