(182 days)
Not Found
No
The summary describes a self-fitting hearing aid system that uses software to guide the user through a fitting procedure and adjust settings based on user input. There is no mention of AI or ML algorithms being used for this process, only a "self-fitting strategy" that integrates user input.
Yes
The device is intended to compensate for impaired hearing by amplifying sound for individuals with hearing impairment. This addresses a medical condition, making it a therapeutic device.
No
The device is intended to amplify sound for individuals with hearing impairment and to support the self-fitting and fine-tuning of a hearing aid, which are functions related to treatment/compensation rather than diagnosis of a condition.
No
The device description explicitly states that the system consists of two components: a wireless hearing aid with a self-fitting feature (Vibe SF) and a mobile web application (EasyFit). The Vibe SF wireless hearing aid hardware includes physical components like ear pieces, housing, circuit board, battery, chip, and electroacoustic components. While software is integral to the self-fitting functionality and control, the device 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 Vibe SF self-fitting hearing aid is a device that amplifies sound to compensate for hearing impairment. It works by processing sound from the environment and delivering it to the user's ear.
- Lack of Biological Sample Analysis: The device does not analyze any biological samples from the user. Its function is purely related to sound processing and delivery.
- Intended Use: The intended use is to amplify sound for individuals with perceived hearing impairment, not to diagnose or detect a disease or condition through the analysis of biological samples.
Therefore, the Vibe SF self-fitting hearing aid falls under the category of a medical device, specifically a hearing aid, and not an In Vitro Diagnostic.
N/A
Intended 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'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.
Product codes
QDD
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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Ear
Indicated Patient Age Range
18 years of age or older
Intended User / Care Setting
Direct-to-consumer sale and use without the assistance of a hearing care professional. Home healthcare environment use.
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
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. Patient Population: The devices were tested on 28 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.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Clinical Testing Summary:
Study Type: Single-arm randomized crossover study.
Sample Size: 28 subjects.
Primary Effectiveness Endpoint: 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.
Key Results:
The study met the primary endpoint. 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
§ 874.3325 Self-fitting air-conduction hearing aid.
(a)
Identification. A self-fitting air-conduction hearing aid is a wearable sound amplifying device that is intended to compensate for impaired hearing and incorporates technology, including software, that allows users to program their hearing aids. This technology integrates user input with a self-fitting strategy and enables users to independently derive and customize their hearing aid fitting and settings. A self-fitting air-conduction hearing aid is subject to the requirements in § 800.30 or § 801.422 of this chapter, as applicable.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Clinical data must evaluate the effectiveness of the self-fitting strategy.
(2) Electroacoustic parameters, including maximum output limits, distortion levels, self-generated noise levels, latency, and frequency response, must be specified and tested.
(3) Performance data must demonstrate the electromagnetic compatibility (EMC), electrical safety, and thermal safety of the device.
(4) Software verification, validation, and hazard analysis must be performed.
(5) If the device incorporates wireless technology:
(i) Performance testing must validate safety of exposure to non-ionizing radiation; and
(ii) Performance data must validate wireless technology functions.
(6) Usability testing must demonstrate that users can correctly use the device as intended under anticipated conditions of use.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). 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
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (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
2
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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3
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)-Exempt |
| Wireless 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
4
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-Fitting
Hearing Aid (K220403) | Predicate Device:
BOSE® Hearing Aid
(DEN180026) | Discussion |
|----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | WSAUD A/S | Bose Corporation | Different legal entities |
| FDA Product
Code | QDD | QDD | Same |
| Classification
Regulation | 21 CFR 874.3325 | 21 CFR 874.3325 | Same |
| Indication 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. The
device is intended for
direct-to-consumer sale
and use without the
assistance of a hearing
care professional. | The Bose 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. No
pre-programming or
hearing test is necessary.
The device is intended for
direct-to-consumer sale
and use without the
assistance of a hearing
care professional. | Same intended use.
Nearly identical indication
for use. |
| Physical
Description | In-The-Ear (ITE) | Flexible neckband housing
Earbuds are connected to
the neckband by flexible
wires and on each earbud
is mounted a Bose
StayHear+ eartip; three
sizes of tips are available. | Different form factor.
Biological safety and
human factors testing
support substantial
equivalence. |
| Maximum
Output
Characteristics | Less than or equal to 114
dB SPL (2 cc coupler) | Less than or equal to 120
dB SPL | Adequate for fitting
moderate hearing loss
(55 dBHL) as prescribed
by NAL-NL2 |
| HFA-FOG | 45 dB | 43 dB | Adequate for fitting
moderate hearing loss
(55 dBHL) as prescribed
by NAL-NL2 |
| Power Source | Powered by a zinc-air 1.3
V, 1.2 mAh battery | Powered by a
rechargeable 3.7 V, 250
mAh Li-ion battery pack | Predicate was
rechargeable; subject
device uses off-the-shelf
disposable hearing aid
batteries. Acoustic
measurements support
substantial equivalence. |
| Labelling | Includes applicable
requirements of 21 CFR
801.420 and 801.421. | Includes applicable
requirements of 21 CFR
801.420 and 801.421. | Same |
| Reprocessing | Non-sterile. The hearing | Non-sterile. The Earbud | Same |
| | Subject Device:
Vibe SF Self-Fitting
Hearing Aid (K220403) | Predicate Device:
BOSE® Hearing Aid
(DEN180026) | Discussion |
| | sleeve) may be wiped daily
with a soft, dry tissue. | may be wiped with a soft,
dry cloth. StayHear+ tips
may be rinsed with warm
water and thoroughly dried
before attaching them to
the earbuds. | |
| Biological
evaluation | A biological evaluation
covering all components
with skin contact has been
conducted per ISO 10993-
1, ISO 10993-5 and ISO
10993-10. | Biocompatibility tested:
MEM elution Cytotoxicity
per ISO 10993-5 and
Irritation and Skin
sensitization per ISO
10993-10. | Same |
| Self-fitting
strategy | For the initial setup, users
run an acoustic profiling
test using the hearing aid
devices. The initial setting
is selected based on the
identified profile. The user
adjusts the setting for
comfortable loudness
impression.
For the fine tuning the user
can select from some pre-
defined improvement areas.
The application running on
a mobile phone web
browser uses the current
setting and the desired
improvement to generate a
new setting. The user is
able to acoustically
compare both settings and
select the one which is
preferred for further use. | Users can control and
customize signal
processing parameters to
their hearing needs via the
Bose user interface, which
consists of two Dimension-
Reduced Controllers
(DRCs) ("Loudness" and
"Fine Tuning")
implemented in an
application running on a
mobile device. | Both use proprietary
algorithms for self-fitting.
Clinical testing supports
substantial equivalence. |
| 21 CFR
874.3325
Special controls | Includes applicable
requirements for special
controls for 21 CFR
874.3325 | Includes applicable
requirements for special
controls for 21 CFR
874.3325 | Same |
| 21 CFR
874.3305
Special controls | Includes applicable
requirements for special
controls for 21 CFR
874.3305 | Includes applicable
requirements for special
controls for 21 CFR
874.3305 | Same |
6
7
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.
8
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 | Investigational
Device Arm Total | Control
Arm 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