(182 days)
The Vibe SF seff-fitting hearing aid is 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's hearing needs through software tools. The device is intended for direct-to-consumer sale and use without the assistance of a hearing care professional.
The EasyFit self-fitting web application is intended to support self-fitting and fine-tuning of the Vibe SF hearing aid.
The Vibe SF Self-Fitting Hearing Aid ("Vibe SF") is a self-fitting air conduction hearing aid 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.
The Vibe SF hearing aid is based on WSAUD's wireless hearing aid series Signia Silk 1X (regulated under 21 C.F.R. § 874.3305). However, unlike standard wireless air-conduction hearing aids, the Vibe SF is intended to be sold directly to the end-user without involvement of a hearing care professional. Briefly, the self-fitting hearing aid system consists of two components:
- a) A wireless hearing aid with a self-fitting feature (Vibe SF); and
- b) A mobile web application (EasyFit) to support the self-fitting and fine-tuning of the hearing aid.
The Vibe SF wireless hearing aid hardware includes: Ear pieces (click sleeves), housing, circuit board, battery, chip, and electroacoustic components. The subject device is fitted for bilateral use with a left and right device. Left and right hearing aids are able to communicate with each other over a magnetic inductive wireless link. The instant fit in-the-ear (ITE) style of the Vibe SF hearing aid uses Click Sleeves in 4 different sizes to couple with the ear canal. The hearing aids are marked with 'R' for right and 'L' for left, and are powered by standard (non-rechargeable) Zinc-Air batteries (size 10A). The Vibe SF hearing aid includes software that communicates with the EasyFit app to provide self-fitting functionality.
The Vibe SF is fitted by the user through the EasyFit self-fitting web application, which is run on an Internet browser on the user's mobile device (smartphone or tablet with iOS or Android operating system). The EasyFit self-fitting web application guides the user through the selffitting procedure and also allows the user to set audiological gain parameters and preferred settings on the Vibe SF Hearing Aid. In addition, a software application (app for iOS and Android) called Vibe app is available as remote control for adjusting volume during daily use.
Here's a breakdown of the acceptance criteria and study details for the Vibe SF Self-Fitting Hearing Aid, based on the provided text:
Acceptance Criteria and Reported Device Performance
The primary objective of the clinical study was to demonstrate non-inferiority of the Vibe SF self-fitting strategy compared to an audiologist-fit (HCP fit) strategy regarding perceived hearing aid benefit. This was measured using the Abbreviated Profile of Hearing Aid Benefit (APHAB) subscales for ease of communication (EC), background noise (BN), and reverberant room (RV).
The acceptance criterion for effectiveness was simultaneous non-inferiority on all three APHAB subscales.
| Acceptance Criterion (Effectiveness) | Reported Device Performance |
|---|---|
| Non-inferiority of Vibe SF self-fitting strategy compared to HCP-fit strategy on all three subscales of APHAB (EC, BN, RV). | Achieved. The Vibe SF strategy was non-inferior to the HCP fit strategy in each of the 3 benefit scores for each subscale in the APHAB (p<0.001 for each subscale/coprimary endpoint). The combined p-value was also <0.001. |
| Acceptance Criterion (Safety) | Reported Device Performance |
| Rate of adverse device effects. | Achieved. No adverse device effects were reported during the study. Two non-device related adverse events (food-related stomach issue, cold virus) and one resolved use error were reported. |
1. Sample Size Used for the Test Set and Data Provenance
- Sample Size (Clinical Study/Test Set): 28 subjects.
- Data Provenance: Single study site in the United States. The study design was a single-arm randomized crossover study, where subjects served as their own control, comparing the self-fitted Vibe SF (investigational device) to the Silk 1X HCP fit (comparator device) in real-life conditions. This indicates a prospective study.
2. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- The ground truth for the "HCP fit" arm was established by a hearing care professional (HCP). The document doesn't specify the exact number of HCPs involved in fitting the devices for the comparison, nor their specific qualifications (e.g., years of experience). However, it implies that the HCP fit leveraged "recognized prescriptive targets from the NAL-NL2" (National Acoustic Laboratories' Nonlinear Version 2).
3. Adjudication Method for the Test Set
- The study was designed as a single-arm randomized crossover study with patients serving as their own control. This means each participant experienced both the self-fit and HCP-fit conditions. Therefore, no external adjudication of results was explicitly described in the context of expert review of the APHAB scores; the "ground truth" for the HCP arm was the HCP's fitting based on NAL-NL2.
4. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No, an MRMC comparative effectiveness study was not done in the traditional sense of evaluating human reader performance with and without AI assistance for interpretation. This study focused on comparing two different fitting strategies (self-fit vs. HCP-fit) for a self-fitting hearing aid, not on improving human clinician interpretation of diagnostic images or data with AI. The device itself (Vibe SF) is the "AI" component, providing the self-fitting algorithm.
5. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
- The study design inherently includes the user as part of the "self-fitting" algorithm's performance, as the user adjusts the device based on the software tools. While the self-fitting algorithm provided by the EasyFit web application is a core component, its performance is measured through the user's interaction and the resulting perceived benefit. Therefore, a pure "algorithm only" standalone performance without any user interaction/input was not explicitly described beyond the fundamental function of the self-fitting software guiding the user. The "Vibe SF strategy" itself is the "algorithm only" aspect, as it is the automated fitting process, but its effectiveness is measured via user outcomes.
6. The Type of Ground Truth Used
- The primary ground truth for the effectiveness endpoint was patient-reported benefit as measured by the APHAB questionnaire.
- For the comparative arm, the "truth" was the fitting performed by a hearing care professional (HCP) adhering to established prescriptive targets (NAL-NL2). This is a form of expert consensus/best practice.
- Secondary endpoints like QuickSIN scores and Real Ear Measurements provided objective measures to support the patient-reported outcomes, comparing the actual performance of the hearing aid with an objective standard (NAL-NL2 targets) for gain.
7. The Sample Size for the Training Set
- The document does not explicitly state the sample size of the training set for the Vibe SF's self-fitting algorithm. The provided information focuses on the clinical validation study (test set) for the device. The proprietary nature of the fitting algorithm suggests that the "training" would have occurred during its development, potentially using a different dataset or real-world data, which is not detailed here.
8. How the Ground Truth for the Training Set Was Established
- Similar to the training set size, the document does not detail how the ground truth for the training set was established for the self-fitting algorithm. It only mentions that the self-fitting strategy uses a "proprietary fitting algorithm" that integrates user input with a self-fitting strategy. This implies that the algorithm's development (and thus its "training") would have involved a methodology to define optimal hearing aid settings, likely based on audiological science, hearing models, and potentially existing patient data, but these specifics are not provided.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
August 12, 2022
WSAUD A/S % John Smith Partner Hogan Lovells US LLP Columbia Square, 555 Thirteenth Street, NW Washington, District of Columbia 20004
Re: K220403
Trade/Device Name: Vibe SF Self-Fitting Hearing Aid Regulation Number: 21 CFR 874.3325 Regulation Name: Self-Fitting Air-Conduction Hearing Aid Regulatory Class: Class II Product Code: QDD Dated: July 14, 2022 Received: July 14, 2022
Dear John Smith:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies.combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's
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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (2 1 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,
Shu-Chen Peng, Ph.D. Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known)
Device Name
Vibe SF Self-Fitting Hearing Aid Indications for Use (Describe)
The Vibe SF seff-fitting hearing aid is 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's hearing needs through software tools. The device is intended for direct-to-consumer sale and use without the assistance of a hearing care professional.
The EasyFit self-fitting web application is intended to support self-fitting and fine-tuning of the Vibe SF hearing aid.
Restricted Device (per 21 CFR 801.420 and CFR 801.421).
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)
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510(k) SUMMARY
WSAUD A/S's Vibe SF Self-Fitting Hearing Aid
Submitter
WSAUD A/S Nymøllevej 6 DK-3540 Lynge Denmark Phone: 0045 21370938 Contact Person: Kristine Klitgaard Pedersen
Date Prepared: August 12, 2022
Name of Device: Vibe SF Self-Fitting Hearing Aid
Common or Usual Name: Hearing Aid
Classification Name: Self-Fitting Air-Conduction Hearing Aid (21 CFR 874.3325)
Regulatory Class: Class II
Product Code: QDD
| Predicate Device: | Bose Corporation | Bose Hearing Aid | DEN180026 |
|---|---|---|---|
| Reference Device: | Sivantos, Inc. | Signia Silk 1X | Class II 510(k)-ExemptWireless Hearing Aid |
Device Description
The Vibe SF Self-Fitting Hearing Aid ("Vibe SF") is a self-fitting air conduction hearing aid 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.
The Vibe SF hearing aid is based on WSAUD's wireless hearing aid series Signia Silk 1X (regulated under 21 C.F.R. § 874.3305). However, unlike standard wireless air-conduction hearing aids, the Vibe SF is intended to be sold directly to the end-user without involvement of a hearing care professional. Briefly, the self-fitting hearing aid system consists of two components:
- a) A wireless hearing aid with a self-fitting feature (Vibe SF); and
- b) A mobile web application (EasyFit) to support the self-fitting and fine-tuning of the hearing aid.
The Vibe SF wireless hearing aid hardware includes: Ear pieces (click sleeves), housing, circuit board, battery, chip, and electroacoustic components. The subject device is fitted for
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bilateral use with a left and right device. Left and right hearing aids are able to communicate with each other over a magnetic inductive wireless link. The instant fit in-the-ear (ITE) style of the Vibe SF hearing aid uses Click Sleeves in 4 different sizes to couple with the ear canal. The hearing aids are marked with 'R' for right and 'L' for left, and are powered by standard (non-rechargeable) Zinc-Air batteries (size 10A). The Vibe SF hearing aid includes software that communicates with the EasyFit app to provide self-fitting functionality.
The Vibe SF is fitted by the user through the EasyFit self-fitting web application, which is run on an Internet browser on the user's mobile device (smartphone or tablet with iOS or Android operating system). The EasyFit self-fitting web application guides the user through the selffitting procedure and also allows the user to set audiological gain parameters and preferred settings on the Vibe SF Hearing Aid. In addition, a software application (app for iOS and Android) called Vibe app is available as remote control for adjusting volume during daily use.
Indications for Use
The Vibe SF self-fitting hearing aid is 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 through software tools. The device is intended for direct-to-consumer sale and use without the assistance of a hearing care professional.
The EasyFit self-fitting web application is intended to support self-fitting and fine-tuning of the Vibe SF hearing aid.
Summary of Technological Characteristics
Both the subject (Vibe SF) and the predicate device (Bose Hearing Aid) are self-fit direct-toconsumer hearing aids indicated for individuals 18 and older with perceived mild to moderate hearing impairment. At a high level, the subject and predicate devices are based on the following same technological elements:
- Self-fit hearing aid.
- Home healthcare environment use. ●
- Software to support self-fitting and fine-tuning of the hearing aid. ●
- Software platform compatibility (iOS, Android). .
The following technological differences exist between the subject (Vibe SF) and predicate device (Bose Hearing Aid):
- . Form factor. Vibe SF has an in-the-ear design while Bose Hearing Aid has a head band design.
- Replaceable battery. Vibe SF uses zinc air batteries and is non-rechargeable. Bose Hearing Aid is rechargeable.
- Proprietary fitting algorithm for self-fitting. .
- . Wireless technologies. Vibe SF has a proprietary e2e (ear-to-ear) wireless technology. Bose Hearing Aid uses Bluetooth.
A table comparing the key features of the subject and predicate devices is provided below.
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| Subject Device:Vibe SF Self-FittingHearing Aid (K220403) | Predicate Device:BOSE® Hearing Aid(DEN180026) | Discussion | |
|---|---|---|---|
| Manufacturer | WSAUD A/S | Bose Corporation | Different legal entities |
| FDA ProductCode | QDD | QDD | Same |
| ClassificationRegulation | 21 CFR 874.3325 | 21 CFR 874.3325 | Same |
| Indication foruse | The Vibe SF self-fittinghearing aid is intended toamplify sound forindividuals 18 years of ageor older with perceivedmild to moderate hearingimpairment. It is adjustedby the user to meet theuser's hearing needsthrough software. Thedevice is intended fordirect-to-consumer saleand use without theassistance of a hearingcare professional. | The Bose Hearing Aid isintended to amplify soundfor individuals 18 years ofage or older with perceivedmild to moderate hearingimpairment. It is adjustedby the user to meet theuser's hearing needs. Nopre-programming orhearing test is necessary.The device is intended fordirect-to-consumer saleand use without theassistance of a hearingcare professional. | Same intended use.Nearly identical indicationfor use. |
| PhysicalDescription | In-The-Ear (ITE) | Flexible neckband housingEarbuds are connected tothe neckband by flexiblewires and on each earbudis mounted a BoseStayHear+ eartip; threesizes of tips are available. | Different form factor.Biological safety andhuman factors testingsupport substantialequivalence. |
| MaximumOutputCharacteristics | Less than or equal to 114dB SPL (2 cc coupler) | Less than or equal to 120dB SPL | Adequate for fittingmoderate hearing loss(55 dBHL) as prescribedby NAL-NL2 |
| HFA-FOG | 45 dB | 43 dB | Adequate for fittingmoderate hearing loss(55 dBHL) as prescribedby NAL-NL2 |
| Power Source | Powered by a zinc-air 1.3V, 1.2 mAh battery | Powered by arechargeable 3.7 V, 250mAh Li-ion battery pack | Predicate wasrechargeable; subjectdevice uses off-the-shelfdisposable hearing aidbatteries. Acousticmeasurements supportsubstantial equivalence. |
| Labelling | Includes applicablerequirements of 21 CFR801.420 and 801.421. | Includes applicablerequirements of 21 CFR801.420 and 801.421. | Same |
| Reprocessing | Non-sterile. The hearing | Non-sterile. The Earbud | Same |
| Subject Device:Vibe SF Self-FittingHearing Aid (K220403) | Predicate Device:BOSE® Hearing Aid(DEN180026) | Discussion | |
| sleeve) may be wiped dailywith a soft, dry tissue. | may be wiped with a soft,dry cloth. StayHear+ tipsmay be rinsed with warmwater and thoroughly driedbefore attaching them tothe earbuds. | ||
| Biologicalevaluation | A biological evaluationcovering all componentswith skin contact has beenconducted per ISO 10993-1, ISO 10993-5 and ISO10993-10. | Biocompatibility tested:MEM elution Cytotoxicityper ISO 10993-5 andIrritation and Skinsensitization per ISO10993-10. | Same |
| Self-fittingstrategy | For the initial setup, usersrun an acoustic profilingtest using the hearing aiddevices. The initial settingis selected based on theidentified profile. The useradjusts the setting forcomfortable loudnessimpression.For the fine tuning the usercan select from some pre-defined improvement areas.The application running ona mobile phone webbrowser uses the currentsetting and the desiredimprovement to generate anew setting. The user isable to acousticallycompare both settings andselect the one which ispreferred for further use. | Users can control andcustomize signalprocessing parameters totheir hearing needs via theBose user interface, whichconsists of two Dimension-Reduced Controllers(DRCs) ("Loudness" and"Fine Tuning")implemented in anapplication running on amobile device. | Both use proprietaryalgorithms for self-fitting.Clinical testing supportssubstantial equivalence. |
| 21 CFR874.3325Special controls | Includes applicablerequirements for specialcontrols for 21 CFR874.3325 | Includes applicablerequirements for specialcontrols for 21 CFR874.3325 | Same |
| 21 CFR874.3305Special controls | Includes applicablerequirements for specialcontrols for 21 CFR874.3305 | Includes applicablerequirements for specialcontrols for 21 CFR874.3305 | Same |
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Performance Data
Non-Clinical Testing Summary
Performance testing was conducted to demonstrate that the Vibe SF Self-Fitting Hearing Aid is as safe and effective as the Bose Hearing Aid. WSAUD conducted a series of non-clinical tests on the Vibe SF to assess electrical safety. EMC, wireless coexistence, electroacoustic performance, usability, biocompatibility, and software. The results are summarized in the table below:
| Test Standard/Method | Test Purpose/Description | Result |
|---|---|---|
| ISO 10993-1:2018 | Biocompatibility | Pass |
| ISO 10993-5:2009 | Pass | |
| ISO 10993-1:2010 | Pass | |
| IEC 62304:2006+A1:2015 | Software | Pass |
| IEC 60601-1:2005/AMD1:2012/AMD2:2020 | Electrical Safety | Pass |
| IEC 60601-2-66:2019 | ||
| IEC 60601-1-11:2015/AMD1:2020 | ||
| IEC 60601-1-2:2014/AMD1:2020 | Electromagnetic Compatibility | Pass |
| AAMI TIR 69:2017 | Wireless Coexistence | Pass |
| ANSI C63.27:2017 | ||
| ANSI/ASA S3.22:2014 | Electroacoustic | Pass |
| ANSI/CTA 2051:2017 | ||
| IEC 60601-1-6:2010/AMD1:2013/AMD2:2020 | Usability Engineering | Pass |
| IEC 62366-1:2015/AMD1:2020 |
In all instances, the Vibe SF Self-Fitting Hearing Aid functioned as intended and results observed were as expected.
As noted in the above table, a human factors validation test was performed to demonstrate that the Vibe SF can be used safely and effectively, per its labeling, by representative intended users, for the intended uses and in the intended use environments. The results indicated that any remaining residual use-related risks were acceptable and were outweighed by the benefits derived from use of the device.
Labeling mitigations were implemented on the Vibe SF box labeling and in the Vibe SF Instructions for Use ("IFU") to help potential users with the self-selection process. These included clarification of the intended users of the device, identifications in which the device may and may not be appropriate, and informing users of the device's limitations and the value of a professional hearing loss evaluation.
Clinical Testing Summary
WSAUD performed a pivotal clinical study to assess the patient-reported benefit from using the self-fitted Vibe SF hearing aid versus the same form factor hearing aid fitted by a hearing care professional ("HCP"). The study was designed as a Single-arm randomized crossover study with patients serving as their own control. It was blinded for some of the secondary endpoints. There was 1 study site in the United States.
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Primary Effectiveness Endpoint: The primary effective of the study was to demonstrate that the Vibe self-fitting (SF) strategy is non-inferior to the audiologist-fit (HCP fit) strategy in subject's perceived hearing aid benefit after using the Vibe SF (investigational device) and Silk 1X HCP fit (comparator device) hearing aids in real-life conditions. Hearing aid benefit was measured by 3 sub-scales of the Abbreviated Profile of Hearing Aid Benefit (APHAB): ease of communication ("EC"), [ability to hear in] background noise ("BN"), and [ability to hear in] a reverberant room ("RV"). The primary endpoint result was comprised of the combined results from these subscales; success required simultaneous non-inferiority of the Vibe SF as compared to HCP fit hearing aid on all three subscales.
Primary Safety Endpoint: The safety endpoint was the rate of adverse device effects.
Patient Population: The devices were tested on 28 subjects. Table 1 shows the baseline demographics of the study subjects. All subjects reported a self-perceived hearing loss, with 71.4% describing their hearing loss with having "A little trouble" and 28.6% with having "A lot of trouble." 4 of the 28 subjects were experienced hearing aid users with a mean of 33 months of hearing aid use.
| Characteristic | Summary |
|---|---|
| Gender | |
| Female | 32.1% (9/28) |
| Male | 67.9% (19/28) |
| Age Group | |
| 25-34 | 3.6% (1/28) |
| 35-44 | 7.1% (2/28) |
| 45-54 | 14.3% (4/28) |
| 55-64 | 25.0% (7/28) |
| 65-74 | 28.6% (8/28) |
| 75-84 | 21.4% (6/28) |
| Ethnicity | |
| Not Hispanic/Latino | 100.0% (28/28) |
| Race | |
| American Indian or Alaska Native | 3.6% (1/28) |
| American Indian or Alaska Native; Other | 3.6% (1/28) |
| White | 92.9% (26/28) |
Table 1. Demographics of the study subjects
The average baseline air conduction audiograms are very similar to the results obtained in a published study with the predicate device (compare Figure 1, which shows the average air conduction audiograms of all participants of the Vibe SF study, and Figure 2 copied from Sabin et al. 20201).
1 A. V. Sabin, D. J. Van Tassel, B. Rabinowitz and S. Dhar (2020). Validation of a self-fitting method for over-thecounter hearing aids. Trends in Hearing, 1-19.
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Image /page/9/Figure/1 description: This image is a graph showing hearing threshold in decibels (dB HL) as a function of frequency in hertz (Hz). The x-axis represents frequency, with values ranging from 250 Hz to 8k Hz. The y-axis represents hearing threshold, with values ranging from -10 dB HL to 100 dB HL. The graph shows that hearing threshold increases as frequency increases, with the lowest threshold at 250 Hz and the highest threshold at 8k Hz.
Figure 1. Average air conduction audiograms for participants in the Vibe SF Study. Error bars reflect standard deviation across all ears.
Image /page/9/Figure/3 description: This image shows a graph comparing the air conduction threshold in dB HL for two groups, labeled 'ABP Group' and 'Self Group', across different frequencies in kHz. The x-axis represents the frequency in kHz, ranging from 0.25 to 8, while the y-axis represents the air conduction threshold in dB HL, ranging from -10 to 100. Both groups show a decrease in air conduction threshold as the frequency increases, indicating better hearing at higher frequencies. Error bars are included to show the standard deviation.
Figure 2. From Sabin et al. 2020.1 Average air conduction audiograms for participants in the ABP (squares) and Self (circles) groups. Error bars reflect standard deviation across all ears in the group. ABP = Audiologist Best Practices.
| Table 2. Patient Accountability | |||
|---|---|---|---|
| -- | -- | -- | --------------------------------- |
| Stage | InvestigationalDevice Arm Total | ControlArm Total | Total |
|---|---|---|---|
| Enrollment | 28 | 28* | 28 |
| Treatment started | 14 | 14 | 28 |
| Treatment finished | 13 | 13 | 26 |
| Primary Safety Endpoint Analysis | 28 | 28* | 28 |
| Primary Effectiveness Endpoint Analysis | 28 | 28* | 28** |
- Cross-over design, patients are the same ones as for investigational device
** 2 subjects had missing HCP fit and Vibe data due to cause but unaided data was collected. Imputed '0' for difference of benefits for those 2 subjects for the intent to treat (ITT) summary.
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Results:
The study met the primary endpoint. The primary effectiveness endpoint results demonstrated that the Vibe SF strategy is non-inferior to the HCP fit strategy in participants' perceived hearing aid benefit. The Vibe SF strategy was non-inferior to the HCP fit strategy in each of the 3 benefit scores for each subscale in the APHAB (p<0.001 for each subscale/coprimary endpoint). Therefore, the Vibe SF strategy demonstrated non-inferiority to the HCP fit strategy (combined p-value <0.001).
As can be seen in Figure 3 below, there is a benefit (positive mean and median values) for both fitting strategies in all domains, suggesting that participants had fewer communication problems with the devices on average. The improvements relative to the unaided condition were significant, but the differences between the HCP fit and Vibe SF devices was not significant. For all subscales, the differences in perceived mean benefit between the two fitting strateqies were very small and significantly lower than the non-inferiority marqins. This means that there should be no clinical difference between the two fitting strategies.
Image /page/10/Figure/4 description: The image is a boxplot comparing APHAB benefit for HCP fit and Vibe SF across three conditions: EC, BN, and RV. The y-axis represents APHAB benefit, ranging from -80 to 80. For each condition, there are two boxplots side by side, one for HCP fit and one for Vibe SF, allowing for a visual comparison of the distributions of APHAB benefit between the two fitting methods.
Figure 3. Results of the APHAB Benefit shown for EC, BN and RV. Boxplots show the mean, median, interquartile range and minimum/maximum. Outliers are indicated with a dot.
To be able to compare the data to the results obtained with the predicate device (Sabin et al. 20201), the global APHAB scores were calculated. The comparison can be seen in Table 3 below. The baseline number of problems is slightly higher in the study population of the Vibe SF Clinical study, but the benefit with the hearing aid is very similar.
| Table 3. Results of APHAB and SSQ Questionnaires, comparison to the data shown in Sabin |
|---|
| et al. 2020¹ for the predicate device |
| APHAB | SSQ | |||||
|---|---|---|---|---|---|---|
| predicate | actual | predicate | actual | |||
| Unaided | Benefit | Unaided | Benefit | Benefit | Benefit | |
| HCP Fit | ||||||
| Mean | 31 | 11.94 | 37.53 | 12.63 | 0.91 | 1.03 |
| SD | 15.22 | 15.14 | 15.37 | 14.05 | 1.93 | 1.4 |
| Min | 12 | -9 | 14.67 | -13.11 | -7.5 | -2.33 |
| Max | 82 | 58 | 71.83 | 37.83 | 4.6 | 3.67 |
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| APHAB | SSQ | |||||
|---|---|---|---|---|---|---|
| predicate | actual | predicate | actual | |||
| Unaided | Benefit | Unaided | Benefit | Benefit | Benefit | |
| N | 34 | 34 | 28 | 26 | 37 | 26 |
| Self | ||||||
| Mean | 31.67 | 14.57 | 37.53 | 11.77 | 1.21 | 1.15 |
| SD | 16.02 | 18.31 | 15.37 | 19.26 | 1.7 | 1.63 |
| Min | 7 | -27 | 14.67 | -19.94 | -1.8 | -2.83 |
| Max | 67 | 54 | 71.83 | 61.44 | 5.3 | 3.67 |
| N | 30 | 30 | 28 | 26 | 28 | 26 |
Secondary Effectiveness Endpoint Results:
EMA Scores: Ecological Momentary Assessment (EMA) scores were similar for the self-fit strategy and HCP fit strategy in each listening situation. Both fitting strategies provided good sound quality and high speech understanding. Sound quality was rated fair to excellent in over 90% of the questionnaires. Median speech understanding was 8 or above on a scale of 0 – 10 (10 signifying "understand every word"), and satisfaction was neutral or better in over 90% of the questionnaires, with 65.5% being satisfied or very satisfied during the HCP fit trial and 75.5% being satisfied or very satisfied during the Vibe SF trial.
QuickSIN Scores: The mean and median results of the QuickSIN test for the HCP fit and for self-fit strategies were very similar, with no significant differences observed (Figure 4). With the devices, programmed to either fitting strategy, on average the participants performed in what would be considered the "normal/near normal" category for SNR-Loss (0-3 dB SNR Loss; e.g., only slightly poorer than someone with normal hearing). The QuickSIN was administered at what was considered to be an ecologically appropriate level of 50 dB HL (~62 dB SPL). At this level, slightly above average speech, we would not expect to see differences between the fitting strategies given the small differences between aided ear canal SPL, and the fact that the participants had mild-to-moderate hearing losses.
Image /page/11/Figure/5 description: The image is a boxplot comparing QuickSiN [dB SNR loss] for unaided, HCP fit, and Vibe SF conditions. The y-axis represents QuickSiN loss, ranging from -4 to 10. The boxplots show the distribution of QuickSiN loss for each condition, with the median marked by an 'X'. The HCP fit condition appears to have the highest median QuickSiN loss, while the unaided condition has the lowest.
Figure 4. QuickSIN results for unaided, HCP fit and Vibe SF, speech presented at 50 dB HL. Boxplots showing the mean ("x"), median, interquartile range and minimum/maximum.
SSQ-12 Scores: In all of the aspects of hearing assessed by the SSQ-12 (domains included following speech, location and distance hearing, qualities of speech), results showed a benefit compared to unaided hearing for both fitting strategies. There was virtually no difference in
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SSQ-12 scores between the HCP fit and the self-fit results. As can be seen in Table 1 (above with APHAB), SSQ-12 Benefit was also very similar to that observed with the predicate device.
Gain Selection: Real ear measurements of both the self-fit and the HCP fit devices showed similar amplification across all measured frequencies, consistent with the National Acoustic Laboratories' Nonlinear Version 2 (NAL-NL2) targets. The HCP-adjusted devices provided slightly greater amplification at higher frequencies. These results are similar to those reported for the predicate device in Sabin et al. 2020, 1 where the self-selected settings correlated with, but were lower than, the HCP-selected settings.
It is also noteworthy that the NAL-NL2 algorithm offers target calculation corrections for new users. 24 of the 28 participants in the study were new users. Several of them had hearing losses to the degree that their fitting targets would have been lowered by hearing care professionals by 2-3 dB, or maybe more. Hence, the real-life mismatch from the NAL-NL2 targets for the SF approach shown in our mean data would not be quite as large as suggested. Furthermore, the Vibe SF hearing aid does provide for user adjustments to increase or decrease gain. Most appropriate for matching to NAL-NL2 targets are adjustment options including overall master gain adjustment for the entire frequency response as well as adjustments for speech intelligibility.
Image /page/12/Figure/4 description: The image contains two line graphs comparing frequency in Hz to decibels. The left graph compares "Target NAL-NL2" and "REAR Vibe SF" in terms of "Rear Ear Target / REAR 65 [dB SPL]" from 250 Hz to 8k Hz. The "Target NAL-NL2" line ranges from approximately 58 dB to 50 dB, while the "REAR Vibe SF" line ranges from approximately 58 dB to 42 dB. The right graph shows the "Difference from Target [dB]" from 250 Hz to 8k Hz, ranging from approximately 4 dB to -8 dB.
Figure 5. (Left) NAL-NL2 Tarqet and measured REAR (real ear aided response) for medium input averaged across all subjects for Vibe SF. (Right) Average and standard deviation of the difference between NAL-NL2 target and measured responses computed across all subjects.
Fitting Preference: An equal number of participants preferred using the HCP fit hearing aids as the self-fit hearing aids (each around 40%). The remaining 20% of participants had no preference between the two fitting strategies.
Safety Outcomes: No adverse device effects were reported during the study. Two adverse events were reported which were not device or study procedure related. One event was reported as a food-related stomach issue and the other, a cold virus. Both were non-device related and resolved without medical intervention. Additionally, one use error was reported but was resolved without medical incident or untoward clinical signs; thus, it was not recorded as an adverse device effect.
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Summary: This study evaluated the effectiveness of the Vibe self-fitting (SF) strategy for the Vibe SF hearing aids as measured by perceived hearing aid benefit. The data showed strong statistical evidence (p<0.001) that the Vibe SF strategy was non-inferior to an HCP fit strategy that used recognized prescriptive targets from the NAL-NL2. Therefore, this study demonstrates the clinical effectiveness of the Vibe SF strategy. Furthermore, the results of the primary and secondary endpoints are similar to those reported for the predicate device (ABHAB, SSQ, QuickSIN). No adverse device effects were reported during the study.
Conclusion
The Vibe SF Self-Fitting Hearing Aid is as safe and effective as the predicate Bose Hearing Aid. The Vibe SF Self-Fitting Hearing Aid has the same intended use and similar indications, technological characteristics, and principles of operation as its predicate device. In addition, the minor technological differences between the Vibe SF Self-Fitting Hearing Aid and its predicate device raise no new issues of safety or effectiveness. Thus, the Vibe SF Self-Fitting Hearing Aid is substantially equivalent.
§ 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.