(149 days)
Not Found
Unknown
The summary mentions "technology, including software, that allows users to program their hearing aids" and "integrates user input with a self-fitting strategy," but it does not explicitly state whether this strategy utilizes AI or ML. The absence of mentions of AI, DNN, or ML, and the lack of details on training/test sets, make it impossible to confirm the presence of these technologies based solely on this summary.
Yes
The device is intended to amplify sounds for individuals with hearing impairment, which is a form of therapy to compensate for a functional loss.
No
The device is described as a "wearable sound-amplifying device intended to compensate for impaired hearing" and its intended use is to "amplify sounds." It does not claim to identify, analyze, or diagnose a medical condition.
No
The device description explicitly states that the device consists of both "hardware and software," including the hearing aids themselves which are powered by batteries and have physical components like microphones and receivers.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Soundwave Hearing Sontro® Self-Fitting OTC Hearing Aids are designed to amplify sound to compensate for hearing impairment. They are wearable devices that interact with the user's auditory system directly, not by analyzing biological samples.
- Intended Use: The intended use clearly states the device is for amplifying sounds for individuals with perceived mild to moderate hearing impairment. This is a functional aid, not a diagnostic test.
- Device Description: The description details the hardware and software for sound amplification and user customization, with no mention of analyzing biological samples.
- Performance Studies: The performance studies focus on the device's ability to amplify sound effectively and be used by the intended users, not on the accuracy of detecting a condition from a biological sample.
Therefore, based on the provided information, the Soundwave Hearing Sontro® Self-Fitting OTC Hearing Aids fall under the category of a hearing aid, which is a medical device but not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Soundwave Hearing Sontro® Self-Fitting OTC Hearing Aids are intended to amplify sounds for use by individuals 18 years and older with perceived mild to moderate hearing impairment. The device is intended for over-the-counter sale and 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 soundamplifying device intended to compensate for impaired hearing. It incorporates technology, including software, that allows users to program their hearing aids. This technology integrates user input with a self-fitting strategy, enabling users to independently derive and customize their hearing aid fitting and settings. This is an over-the-counter hearing aid.
The Soundwave Hearing, Sontro® OTC (over-the-counter) Hearing Aids are self-fitting wireless air conduction hearing aids consisting of the hardware and software: the device uses the otoTune® app and accessories supplied in the carton. Each hearing aid in the pair functions and interacts with the otoTune® app independently and as a system.
A disposable size 312 zinc-air battery powers the hearing aids. The hearing aids incorporate microphones for audio input, and sound is delivered to the ear via a receiver in the canal that can be coupled with ear domes. The hearing aids are controlled via onboard button controls and wirelessly via the otoTune® app (iOS and Android). The controls allow the user to configure parameters, settings, and listening modes.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Sontro® OTC Hearing Aids (AI)
Input Imaging Modality
Not Found
Anatomical Site
Ear
Indicated Patient Age Range
18 years of age or older
Intended User / Care Setting
Use without the assistance of a hearing care professional.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Twenty-nine patients enrolled in the study, 13 men and 16 women. Seventeen subjects withdrew due to poor compliance or personal reasons. The age of the enrolled patients ranged from 31 to 75 years, on average 58.9 ± 11.7.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Clinical Study (Validation Component and Reliability Component) and Usability Testing.
Sample Size: 29 participants for the clinical study, 17 untrained participants for usability testing.
Key results for clinical study:
- REAR: "The point estimate shows that the average of the differences CLINIC-Fit REAR - SLEF-FIT REAR is within -5 dB and 5 dB. Non-inferiority is demonstrated." "Using all ears, SELF-FIT procedure trial A and trial B lead to similar outcomes. Noninferiority is demonstrated."
- APHAB: "Noninferiority is demonstrated for the in-lab APAHAB SELF-FIT condition when compared with the CLINIC-FIT condition."
- QuickSIN: "Non-inferiority is demonstrated for the in-lab SELF-FIT Procedure." "SELF-FIT procedure trial A and trial B lead to similar outcomes. Non-inferiority is demonstrated." "Noninferiority is demonstrated for the SELF-FIT procedure."
- Safety: "No adverse events were reported during the clinical trial."
Key results for usability testing: "Usability Testing indicates that the subject device and app are able to be used correctly for the intended user, uses, and environment."
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Primary Effectiveness Endpoints:
- Real-Ear Aided Response (REAR) non-inferiority margins at +/-5 dB (-5 dB ≤ CLINIC-FIT REAR – SELF-FIT REAR ≤ 5 dB).
- Real-Ear Aided Response (REAR) non-inferiority margins at +/-5 dB (-5 dB ≤ SELF-FIT A -- SELF-FIT B ≤ 5 dB).
- APHAB global score non-inferiority margin of
§ 874.3325 Self-fitting air-conduction hearing aid.
(a)
Identification. A self-fitting air-conduction hearing aid is a wearable sound amplifying device that is intended to compensate for impaired hearing and incorporates technology, including software, that allows users to program their hearing aids. This technology integrates user input with a self-fitting strategy and enables users to independently derive and customize their hearing aid fitting and settings. A self-fitting air-conduction hearing aid is subject to the requirements in § 800.30 or § 801.422 of this chapter, as applicable.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Clinical data must evaluate the effectiveness of the self-fitting strategy.
(2) Electroacoustic parameters, including maximum output limits, distortion levels, self-generated noise levels, latency, and frequency response, must be specified and tested.
(3) Performance data must demonstrate the electromagnetic compatibility (EMC), electrical safety, and thermal safety of the device.
(4) Software verification, validation, and hazard analysis must be performed.
(5) If the device incorporates wireless technology:
(i) Performance testing must validate safety of exposure to non-ionizing radiation; and
(ii) Performance data must validate wireless technology functions.
(6) Usability testing must demonstrate that users can correctly use the device as intended under anticipated conditions of use.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
October 26, 2023
% Kyle Rose CEO, Rook Quality Systems Rook Quality Systems, Inc. 1155 Mount Vernon Highway, Suite 800 Dunwoody, Georgia 30338
Re: K231550
Trade/Device Name: Sontro® OTC Hearing Aids (AI) Regulation Number: 21 CFR 874.3325 Regulation Name: Self-Fitting Air-Conduction Hearing Aid Regulatory Class: Class II Product Code: QUH Dated: September 26, 2023 Received: September 27, 2023
Dear Kyle Rose:
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 (the Act) that do not require appro val 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
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Your device is also subject to, among other requirements, the Quality System (OS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100. Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.70) and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrl-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Shuchen Peng -S Shu-Chen Peng, Ph.D. Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
2
Indications for Use
See PRA Statement below.
510(k) Number (if known) K2311550
Device Name Sontro® OTC Hearing Aids
Indications for Use (Describe)
The Soundwave Hearing Sontro® Self-Fitting OTC Hearing Aids are intended to individuals 18 years of age or older with perceived mild to moderate hearing impairment. They are to meet the user's hearing needs. The device is intended for use without the assistance of a hearing care professional.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) | |
|---|---|---|
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510 K Summary K231550
| Preparation Date: | September 21, 2023 |
|---|---|
| ------------------- | -------------------- |
Applicant Name and Address
| Company Name: | Soundwave Hearing, LLC |
|---|---|
| Address: | 619 Enterprise Drive, Suite #205 |
| Oak Brook, IL 60523 |
Official Contact:
| Anthony Florek | |
|---|---|
| President & Founder, Soundwave Hearing, LLC | |
| Telephone: | 708-205-7998 |
| Email: | aflorek@hearsoundwave.com |
Representative/Consultant
| Company: | Rook Quality Systems |
|---|---|
| Address: | 1155 Mount Vernon Hwy, Suite 800 |
| Dunwoody, GA 30338 |
| Contact: | Kyle Rose |
|---|---|
| Telephone: | 404-717-9358 |
| Email: | kyle.rose@rookqs.com |
Current Device Information
| Trade/Proprietary Name | Sontro® Self-Fitting OTC Hearing Aids |
|---|---|
| Common Device Name | Self-Fitting Wireless Air-Conduction Hearing Aid, Over-the- |
| Counter | |
| Classification Name | Self-Fitting Wireless Air-Conduction Hearing Aid, Over-the- |
| Counter | |
| Regulation Number | 21 CFR 874.3325 |
| Product Code(s) | QUH |
| Classification | Class II |
| Review Panel | Ear, Nose, and Throat Devices |
| Predicate Device | Bose SoundControl Hearing Aid (K211008) |
| Use | Over-the-Counter (OTC) |
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1. Device Description
Per 21 CFR 874.3325, a self-fitting wireless air-conduction hearing aid is a wearable soundamplifying device intended to compensate for impaired hearing. It incorporates technology, including software, that allows users to program their hearing aids. This technology integrates user input with a self-fitting strategy, enabling users to independently derive and customize their hearing aid fitting and settings. This is an over-the-counter hearing aid.
The Soundwave Hearing, Sontro® OTC (over-the-counter) Hearing Aids are self-fitting wireless air conduction hearing aids consisting of the hardware and software: the device uses the otoTune® app and accessories supplied in the carton. Each hearing aid in the pair functions and interacts with the otoTune® app independently and as a system.
A disposable size 312 zinc-air battery powers the hearing aids. The hearing aids incorporate microphones for audio input, and sound is delivered to the ear via a receiver in the canal that can be coupled with ear domes. The hearing aids are controlled via onboard button controls and wirelessly via the otoTune® app (iOS and Android). The controls allow the user to configure parameters, settings, and listening modes.
2. Intended Use
The Soundwave Hearing Sontro® Self-Fitting OTC Hearing Aids are intended to amplify sounds for use by individuals 18 years and older with perceived mild to moderate hearing impairment. The device is intended for over-the-counter sale and use without the assistance of a hearing care professional.
3. Indications for Use
The Soundwave Hearing Sontro® Self-Fitting OTC 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.
4. Device Information
Per 21 CFR 874.3325, a self-fitting wireless air-conduction hearing aid is a wearable soundamplifying device intended to compensate for impaired hearing. It incorporates technology, including software, that allows users to program their hearing aids. This technology integrates user input with a self-fitting strategy, enabling 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 users to adjust the volume setting and customize the hearing mode program.
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5. Self-Selection Labeling
Self-selection labeling has been included in the Sontro Self-Fitting OTC Hearing Aid's IFU to mitigate the risk of improper self-selection. Summarized, it addresses:
- A warning against the use of people younger than 18 years of age. .
- Identifying criteria that indicate the user should see a hearing professional. ●
- Identifying situations where Sontro Self-Fitting OTC Hearing Aids may help you hear better.
- Identifying situations in which Sontro Self-Fitting OTC Hearing Aids may not be suitable ● for the user.
- Informing the user that the Sontro Self-Fitting OTC Hearing Aids will not restore normal hearing.
- Informing the user that it is good health practice to have hearing loss evaluated by an ● appropriate healthcare professional.
6. Special Controls
The Sontro Self-Fitting OTC Hearing Aids conform to the special controls stated in 21 CFR 874.3325. Soundwave has satisfied these requirements through:
- . Clinical Data
- Non-Clinical Performance Testing ●
- Human Factors Validation ●
- Labeling .
7. Comparison of Technological Characteristics
The subject (Sontro Self-Fitting OTC Hearing Aid) and the predicate (Bose SoundControl Hearing Aid) are self-fit hearing aids. The predicate device is considered direct-to-consumer since it was cleared before the finalization of the OTC Hearing Aid Rule; the subject device is an over-the-counter hearing aid. Both the predicate and subject devices are indicated for individuals 18 and older with perceived mild to moderate hearing impairment. The same fundamental technology is present in both the predicate and subject hearing aids to allow the user to control and customize the device to the user's hearing needs.
Both devices contain the same technological characteristics:
- Self-Fit Hearing Aid ●
- Bluetooth
- On Device Controls ●
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- A traditional receiver-in-the-canal (RIC) style form factor ●
- Replaceable 312 Battery .
- Software App .
- Software Platform Compatibility (iOS, Android) .
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Substantial Equivalence Technological Comparison Summary:
Table 1 Soundwave Hearing conducted a comprehensy technological comparison between the Sontro® Self-Fiting OTC Hearing Aids and the predicate device (K211008) to facilitate substantial equivalence.
| Topic | Subject Device (Sontro®
Self- Fitting OTC Hearing
Aid) | Predicate Device
(Bose SoundControl
Hearing Aid) | Discussion of Similarities and Differences |
|---------|-----------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Fitting | Self-Fit
Apply personalized gain
settings based on user
in-situ test.
Utilizes the validated NAL-
NL2 fitting algorithm. | Self-Fit
Loudness and Fine-Tuning.
Utilizes a proprietary fitting
algorithm. | Similarities: Both the predicate and subject devices use
proprietary software to program the user's hearing needs
to the devices. This self-fitting is done after assessing
the user's hearing loss has been assessed by the software
Differences: The subject has three patents for self-
fitting, which are used in the software applying
personalized gain settings based on a user in-situ test
and utilizing the validated NAL-NL2 fitting
algorithm, personalizing the hearing threshold to the
user's unique requirements for hearing amplification.
There are no pre-suite hearing thresholds for the
software to choose from. The Predicate utilizes a
proprietary fitting algorithm, fitting one of several
programs that best match the user's hearing threshold
with loudness and fine-tuning by the user.
NAL-NL2 is widely used by hearing professionals.
Clinical and non-clinical testing supports the subject
device's equivalence to the predicate despite
technological differences. Clinical and non-clinical
testing performed are detailed in this summary. |
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| Intended user
Population | 18+ Years Old | 18+ Years Old | The same: The subject and predicate are intended
for an 18+ population. This is the intended
population requirement in the OTC hearing Aid
Rule. |
|-----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for
Use | The Soundwave Hearing
Sontro® Self-Fitting OTC
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. | The Bose SoundControl
Hearing Aids are
intended to amplify
sound for adults 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
preprogramming or
hearing test is necessary.
The device is intended
for direct-to-consumer
sales without the
assistance of a hearing
care professional. | Similar: The subject Indications for Use is similar to the
predicate, with the appropriate adjustments in accordance
with the OTC Hearing Aid Final Rule. |
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| Technology | Wireless, self-fitting air-
conduction hearing aid | Wireless, self-fitting
air-conduction hearing
aid | The same: The technology between the subject and
predicate is the same. The predicate and subject use
(RIC) Receiver in the canal technology. |
|------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Housing | Behind the ear hearing aid
housing. Speakers
(receiver) and domes that
insert into each ear separate
left and right ear devices
with user-control push
buttons on each unit.
Image: Hearing aid diagram with labels for receiver, volume button, open ear dome, microphone, and battery door. | Behind the ear hearing aid
housing. Speakers
(receiver) and domes that
insert into each ear separate
left and right ear devices
with user-control push
buttons on each unit.
Image: Hearing aid diagram with labels for eartip, speaker, cable, battery door, world volume up button, microphones, hearing aid body, and world volume down button. | Similarities: The subject and predicate design are
similar; they are BTE with receivers and domes that
insert into each ear with separate left and right ear
devices with user control push buttons on each unit.
Differences: The shapes of the subject and predicate
device housings are slightly different in design.
The design differences were tested with a Usability
study. Participants were asked questions relating to
the physical appearance and comfort of the subject
device, with a passing result once responses were
evaluated. |
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| Dimensions | Overall, without cable:
27.2 mm long (height)
13.2 mm wide (depth) X
7.8 mm thick (width) | Overall, with cable:
33 mm long x 23 mm wide
x 18 mm thick | Similarities: The subject and the predicate design are
similar; they are both BTE with receivers and domes
that insert into each ear with separate left and right ear
devices with user control push buttons on each unit.
Differences: The shapes of the subject and predicate
device housings are slightly different in design.
The design differences were tested with a Usability
study. Participants were asked questions relating to
the physical appearance and comfort of the subject
device, with a passing result once responses were
evaluated. |
|-----------------------------|----------------------------------------------------------------------------------------------------|------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Expected
Service
Life | 2 years | 2 years | The same: The expected service life between the
subject and predicate is the same. |
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| On
Device
Controls | Yes | Yes | Similarities: The subject and the predicate design are
similar, with user-control push buttons on each unit.
Differences: The subject's shape and predicate device
controls differ slightly in design.
The design differences were tested with a Usability
study. Participants were asked questions relating to
the modes and settings of the subject device, with a
passing result once responses were evaluated. |
| -------------------------- | ----- | ----- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
|---|
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| Bluetooth | 2.4 GHz | 2.4 GHz | The Same: The Bluetooth connection between the
subject and predicate is the same. |
|---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Wireless
communication | Wireless
communication
with
handheld
device
via
Bluetooth | Wireless
communication
with
handheld
device
via
Bluetooth | The Same: The wireless communication between the
device and the handheld device (software) is the same
between the subject and predicate. |
| Wireless
coexistence | The Sontro® OTC Hearing
Aid uses standard 2.4GHz
Classic Bluetooth and
Bluetooth Low Energy
(BLE) standards to
communicate between the
hearing aid and the user's
Bluetooth-enabled device.
From the risk assessment,
the temporary loss of
Bluetooth communication
from interfering RF signals
is appropriately considered a
negligible risk, and
according to AAMI TIR 69,
wireless coexistence testing
is not required. Note that the | The Bose BMD-0012
Hearing Aid uses standard
2.4GHz Classic Bluetooth
and Bluetooth Low Energy
(BLE) standards to
communicate between the
hearing aid and the user's
Bluetooth-enabled device.
From the risk assessment,
the temporary loss of
Bluetooth communication
from interfering RF signals
is appropriately considered
a negligible risk, and
according to AAMI TIR 69,
wireless coexistence testing | The Same: The wireless coexistence between the
device and the handheld device (software) is the same
between the subject and predicate. Both use 2.4GHz
classic Bluetooth Low Energy (BLE) standards to
communicate between the hearing aid and the user's
Bluetooth-enabled device. |
| | is not required. Note that | | |
| | the | | |
| | | | |
| | | | |
| | | | |
| | | | |
| | | | |
| | | | |
| | | | |
| | | | |
| | | | |
| | | | |
| | | | |
| | | | |
| | | | |
| | | | |
| | | | |
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14
| | interruption of device
control from the App
would be similar to when
the user is separated from
their Bluetooth-enabled
device. | interruption of device
control from the App
would be similar to when
the user is separated from
their Bluetooth-enabled
device. | |
|---------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Wireless user
control
functions via
mobile app | Volume Control Modes
Quiet - Omnidirectional
mic Noise - Adaptive mic
Entertainment - Fixed
Forward mic
Left/Right independent
control. | Volume Control Modes
Focused, Conversation,
Outdoors, Music, Television
Mic Control
Everywhere, Front
Left/Right Balance | Similarities: Both the subject and predicate software
have the ability for the user to control: Volume,
modes, and two microphones. The subject and the
predicate devices allow for omnidirectional and
speech-focus speech options. Omnidirectional and
speech-focused options, both devices work within the
same 120-degree focus.
Differences: Subject device modes, microphones, and
left/right balance differ in technological function and
naming. |
15
| The Sontro® OTC
Hearing Aids use two
microphones on the
device, which allow for
directionality. This
directionality operates
specifically in the three
modes of operation. | The Bose Predicate device
has two microphones on the
device, which, during use,
may be configured by the
user to be Everywhere (360
degrees) or in Front (fixed
120 degrees forward)
direction of operation. | The additional functionality of the left/right balance of
the predicate device does not raise questions of safety or
effectiveness for the device.
The added Adaptive directionality of the subject device
does not raise questions about the safety or effectiveness
of the device.
Clinical and non-clinical data from a usability study
and data from a clinical validation study support |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| When the device is in
Quiet Mode, the
microphones work omni-
directional or 360
degrees. While in
Entertainment Mode, the | | substantial equivalence. Additionally, a usability study
was performed where participants were asked
questions regarding the mode and settings, with a
passing result once the results were evaluated. |
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| | Microphones work in a
fixed forward direction
with a spread of 120
degrees. While in Noise
Mode, the microphones
work in a forward cone of
120 degrees, but the focus
is towards the loudest
human speech, called
Adaptive Directionality. | | |
|---------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|
| Demonstrate
that the hearing
Aid device
initiates
Bluetooth
pairing and
Bluetooth
control
functionality | Pairing and control with the
paired mobile device. | Pairing and control with the
paired mobile device. | The Same: Both the subject and predicate devices use
Bluetooth capabilities to pair the devices with the
software on the handheld device. |
| Battery | Hearing Aid with a single
replaceable 312 zinc-air
cell 1.5V, 4 day, 14hr/day
battery coin cell | Hearing Aid with a single
replaceable 312 zinc-air
cell 1.5V, 4 day, 14hr/day
battery coin cell | The Same: Both the subject and the predicate use a
single replaceable 312 zinc-air 1.5V, 4day, 14hr/day
battery, coin cell |
| Battery Life | Up to four days
assuming 14hr day
usage, depending on the
brand and age of
batteries | Up to four days
assuming 14hr day
usage, depending on the
brand and age of
batteries | The Same: Both the subject and the predicate use a
single replaceable 312 zinc-air 1.5V, 4day, 14hr/day
battery, coin cell |
17
18
| Microphones | During use, the earbuds'
microphone may be
configured by the user in
the following modes: Quiet
mode (Omnidirectional
360- degrees degree),
Entertainment mode (Fixed
Directionality 120-degree
Speech focused), or Noise
Mode (Adaptive
Directionality 120-degree) | During use, the earbuds'
microphone may be
configured by the user in
the following modes:
Everywhere mode
(Omnidirectional 360-
degree) or Front mode
(Fixed Directionality 120-
degree Speech focused). | Similarities: The subject and predicate devices allow
omnidirectional 360-degree and speech-focus 120-
degree options.
Differences: The subject device supports an additional
adaptive directional 120-degree noise mode that allows
the earbuds to determine the most suitable directionality
for the microphones for the given environment,
dynamically changing the directional pattern to reduce
the loudest sounds from the rear.
The added automatic selection of directionality does notNonclinical data from a usability study and data from a
clinical validation study support substantial equivalence. |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Control | On-Device user controls:
- Volume up/down
- Mode change
- Bluetooth Pairing
- Clearing out hearing
aid setting | On-Device user controls: - Volume up/down
- Mode change
- Bluetooth Pairing
- Clearing out hearing
aid setting | The Same: Both the subject and the predicate use on-
device user controls of a rocker switch that allows for
the following: volume up/down, mode change,
Bluetooth pairing, and clearing out the hearing aid
setting. |
| Compression | 16-channel wideband
dynamic range compression | 12-channel wideband
dynamic range compression | Similarities: The subject and the predicate use
wideband dynamic range compression |
| | | | Differences: The subject uses 16 channels, and the
predicate uses 12 channels |
| | | | The 4 additional channels on the subject device are
added into the base, mid, and treble and offer similar
spectral tilt as the predicate device. The channels are
equal divisions of the frequency spectrum from 200 Hz
to 8000 Hz. Both the predicate and Sontro® Self-Fitting
OTC Hearing Aids share the same spectrum. However,
the predicate divides this spectrum into 12 sections
(channels) of 650 Hz each, and the subject devicedivides the spectrum into 16 sections (channels) or 488
Hz. Each channel can be amplified to meet the needs of
the user with hearing loss within a channel. The 4
additional channels do not raise different questions of
safety or effectiveness. |
| Noise
Reduction | Active noise reduction.
Impact noise control. | Active noise
reduction. Impact
noise control. | The Same: The subject and the predicate use active
noise reduction with impact noise control. |
| Feedback
Cancellation | Feedback canceller. | Feedback canceller. | The Same: The subject and the predicate use a
feedback canceller. |
| Mobile app | Compatible with iOS and
Android. | Compatible with iOS and
Android. | The Same: The subject and the predicate are compatible
with iOS and Android. |
| Telephony | No | No | The Same: The subject and the predicate do not use
telephony. |
| Streaming | No | No | The Same: The subject and the predicate do not use
streaming. |
| Active Noise
Reduction | No | No | The Same: The subject and the predicate do not use
active noise reduction. |
| Comparison of Subject Modes and Predicate Modes: Quiet vs. Everywhere, microphones pickup 360 Degree sound; Entertainment
vs Front mode, microphones pickup fixed forward sound and Noise mode, microphones pickup dynamic forward sound. | | | |
| Omnidirectiona
1 360 degree | Quiet Mode | Everywhere Mode | Similarities: The subject's Quiet mode, which allows
for 360-degree sound for pickup around the head of the
user, is similar to the predicates Everywhere mode.
Differences: The subject calls this Quiet Mode, and the
predicate calls this Everywhere Mode. |
| Speech Focus
120 degree
Fixed
Directionality | Entertainment Mode | Front Mode | Similarities: The subject's Entertainment mode allows
for 120-degree forward sound pickup while reducing
the sound behind the user, similar to the predicate's
Front mode.
Differences: The subject calls this Entertainment Mode
and the predicate calls this Front Mode. |
| Speech Focus
120 degree
Adaptive
Directionality | Noise Mode | N/A | Similarities: Noise mode is not available on the
predicate.
Differences: Noise Mode also allows 120 degrees of
sound pick up, similar to the subject's Entertainment
mode. However, the sound pickup will move to a
person speaking without the users being required to
move their heads in that direction. The Subject's Noise
mode benefits the user, making interacting with a
group more comfortable rather than swiveling their
head to face each person speaking as is required by the
predicate device that does not have a Noise mode. The
subject offers two modes of directionality that the user
can choose from. There is no adverse effect of a
choice between two vs. one of the predicate devices.
Research and studies show the constant increase of
adaptive directionality in bilateral hearing aids and the
benefit to the user. |
19
20
21
22
Conclusion Technological Comparison
As seen in the comparison table, the subject device have the same design principles and similar design features and performance specifications. The differences in technological characteristics between the subject device, Sontro® Self-Fitting OTC Hearing Aid, and the predicate device (K21108) do not raise different questions of safety and effectiveness. No identified hazard requires additional benefit versus risk analysis supporting substantial equivalence.
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8. Substantial Equivalence to Predicate Device
Soundwave Hearing submits the following information to demonstrate that the Sontro® OTC Self-Fitting Hearing Aid is substantially equivalent to the following legally marketed predicate device:
| 510(k)
| Number | Predicate Device Name / Manufacturer |
|---|---|
| K211008 | Bose SoundControl Hearing Aid / Bose |
The Sontro® Self-Fitting OTC Hearing Aids were evaluated through Clinical and Non-Clinical Performance Testing to demonstrate the substantial equivalence to the predicate device as described in (K211008)
The subject device has the same intended use and similar technological characteristics to the device cleared in K211008.
9. Clinical Data:
For the in-lab session, the primary effectiveness endpoint was assessed by the differences in acoustical real-ear aided response (REAR), a gold-standard measure for the acoustic function of hearing devices for the study population. This endpoint will assess differences between the mean values after two replications of the SELF-FIT method (reliability) and between the SELF-FIT and CLINIC-FIT methods (validity or effectiveness).
For the wear-time trial, the primary outcome measure is a widely used clinical self-report measure of benefit (Abbreviated Profile of Hearing Aid Benefit, APHAB). The APHAB is also a gold-standard, validated assessment of hearing aid benefits relevant to the study population.
Secondary effectiveness endpoints for the laboratory and field trial components were assessed by a standardized measure of speech communication in noise, the QuickSIN test. This is a widely used clinical measure of an adult's ability to understand speech in noise and is closely tied to the wearer's primary complaint of difficulty communicating in noise.
Overall, the study's success was defined by meeting all primary endpoints for the devices' reliability, effectiveness, and safety and the self-fitting process in this study's laboratory and field trial components. Effectiveness outcomes from the SELF-FIT process were equivalent to those of the CLINIC-FIT method in the in-lab session and non-inferior to CLINIC-FIT in the wear-time trial for the study to be considered successful.
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Study Flow:
Image /page/24/Figure/1 description: The image shows a flowchart of a study design. The first step is Session 1 (in-lab), which leads to two parallel paths: HAs programmed with Clinician-Fit and HAs programmed with Self-Fit. These two paths are connected by arrows indicating a possible switch between the two. Both paths then lead to Session 2 (in-lab) after a 2-week field trial.
Participants/ Demographics
Twenty-nine patients enrolled in the study, 13 men and 16 women. Seventeen subjects withdrew due to poor compliance or personal reasons. The age of the enrolled patients ranged from 31 to 75 years, on average 58.9 ± 11.7.
| able | |
|---|---|
| ------ | -- |
| Total | age_min | age_max | age_avg | age_std | |
|---|---|---|---|---|---|
| Female | 16 | 31 | 75 | 60.5 | 11.6 |
| Male | 13 | 36 | 70 | 56.3 | 11.9 |
| Female + Male | 29 | 31 | 75 | 58.9 | 11.7 |
| by Ethnicity | |||||
| N | (%) | ||||
| White / Caucasian | 23 | 79.4 | |||
| Hispanic | 0 | 0 | |||
| Hispanic / Black | 0 | 0 | |||
| Black / African American | 3 | 10.3 | |||
| Asian | 3 | 10.3 | |||
| Total | 29 | 100 |
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Study Endpoints
Primary Effectiveness Endpoints
For the validation component of the immediate in-lab session comparisons, Real-Ear Aided Response (REAR) was measured using both an audiology-best-practices (professional) hearing aid fitting (CLINIC-FIT) and a self-fitting method (SELF-FIT).
-
. Success criterion is defined as SELF-FIT REAR is equivalent to CLINIC-FIT NAL/NL2 prescription REAR targets based on the average real-ear aided response at 500, 1000, 2000, and 4000 Hz with non-inferiority margins at +/-5 dB (-5 dB ≤ CLINIC-FIT REAR – SELF-FIT REAR ≤ 5 dB).
Real-Ear Aided Response (REAR) was measured twice (A, B) using the SELF-FIT method for the reliability component of the immediate in-lab session comparisons. -
The success criterion is the four-frequency average REAR for SELF-FIT B is equivalent to the REAR for SELF-FIT A based on the average real-ear aided response at 500, 1000, 2000, and 4000 Hz with non-inferiority margins at +/-5 dB (-5 dB ≤ SELF-FIT A -- SELF-FIT B ≤ 5 dB).
For the wear-time field trial, the APHAB was measured following an audiology bestpractices hearing aid fitting (CLINIC-FIT) and a self-fitting method (SELF-FIT). -
. Success criterion is defined as SELF-FIT APHAB global score is non-inferior to CLINIC-FIT APHAB global scores following completion of the wear-time field trial with a non-inferiority margin of -5dB$ | $CF-(SFA+SFB)/2$ | 0.17 | 0.78 | -0.44 | YES |
| | | primary endpoint 1 | reliability | $95% CI upper bound -1.5 dB$ | $QSIN CF-(QSIN SFA+QSIN SFB)/2$ | -0.38 | 0.18 | -0.94 | YES |
| | | secondary endpoint 2 | reliability | $95% CI lower bound > -1.5 dB$ | $QSIN SFA-QSIN SFB$ | 0.28 | 1.03 | -0.48 | YES |
| | | secondary endpoint 3 | effectiveness | $95% CI lower bound > -1.5 dB$ | $avg(QSIN CF)-avg(QSIN SF)$ | -0.06 | 1.36 | -1.47 | YES |
For all 95% confidence interval calculations, the family-wise rate of making a type-I error was controlled. The Bonferroni method was applied. The significance level was adjusted by the number of observations.
For the primary endpoint: In-lab session 1 compares Real-Ear Aided Response (REAR) SELF-FIT REAR with the CLINIC-FIT NAL/NL2 on the average REAR 500, 1000, 2000 and 4000 Hz.
Analvsis results:
Table 4 shows the average of the REAR differences between CLINIC-FIT and SELF-FIT (CLINIC FIT - SELF-FIT). Results are shown for all ears, left ears, and right ears. The point estimate is 0.17 for all ears (left and right combined). The 95% confidence interval for the difference in both ears is (-0.44, 0.78). The non-inferiority margins are at -5 dB and 5 dB.
27
Conclusion:
The point estimate shows that the average of the differences CLINIC-Fit REAR - SLEF-FIT REAR is within -5 dB and 5 dB. Non-inferiority is demonstrated.
For the primary endpoint: in-lab session 1 compares Real-Ear Aided Response (REAR) SELF-FIT A with SELF-FIT B on the average REAR at 500, 1000, 2000, and 4000 Hz.
Analysis results:
Table 1 shows the averaged differences of the REAR after SELF-FIT-A and SELF-FIT-B. Results are shown for all ears. The point estimate is 0.07 (both ears combined). The 95% confidence interval for the difference in both ears is (-0.88, 0.73). The noninferiority margins are -5 dB and 5 dB.
Conclusion:
Using all ears, SELF-FIT procedure trial A and trial B lead to similar outcomes. Noninferiority is demonstrated.
For the primary endpoint: wear-time field trial session 2 compares the APHAB CLINIC-FIT with SELF-FIT.
Analysis results:
Table 4 shows the averaged differences for the APAHBglobal benefits after two fitting procedures. The point estimate of the effect is 1.93. The 95% confidence interval is (-4.35, 8.21). The non-inferiority margin is 8.4.
Conclusion:
The point estimate favors hearing aid benefits after the CLINIC-FIT procedure. Noninferiority is demonstrated for the in-lab APAHAB SELF-FIT condition when compared with the CLINIC-FIT condition.
For the secondary endpoint: in-lab session 1 compares QuickSIN SELF-FIT with CLINIC-FIT.
Analysis results:
Table 4 shows the averaged differences in Signal-to-Noise (SNR) loss in dB, which were obtained with the QuickSIN test. Results for the two hearing aid fitting procedures are compared, CLINIC-FIT and SELF-FIT. The point estimate of the effect is -0.38. The 95% confidence intervals for the difference is (-0.94. 0.18). The non-inferiority margin is -1.5 dB.
Conclusion:
The point estimate favors the CLINIC-FIT procedure. Non-inferiority is demonstrated for the in-lab SELF-FIT Procedure.
28
For the secondary endpoint: in-lab session 1 compares QuickSIN SELF-FIT A with SELF-FIT B.
Analysis results:
Table 4 shows the averaged differences in Signal-to-Noise (SNR) loss in dB, which were obtained with the QuickSIN test. Results for two hearing aid fitting procedure are compared, SELF-FIT A and SELF-FIT B. The point estimate of the effect is 0.28, favoring the SELF-FIT B procedure. The 95% confidence intervals for the difference is (-0.48, 1.03). The non-inferiority margin is -1.5.
Conclusion:
SELF-FIT procedure trial A and trial B lead to similar outcomes. Non-inferiority is demonstrated.
For the secondary endpoint: wear-time field trial session 2 compares OuickSIN SELF-FIT with QuickSIN CLINIC-FIT.
Analysis results:
Table 4 shows the difference of the average SNR-loss in dB for the wear-time field trial. Results for the CLINIC-FIT and SELF-FIT are compared. The point estimate of the effect is -0.6, favoring the CLINIC-FIT procedure. The 95% confidence intervals for the difference were (-1.47, 1.36). The non-inferiority margin is -1.5.
Conclusion:
The lower bound of the 95% confidence interval, -1.47, is larger than -1.5 dB. Noninferiority is demonstrated for the SELF-FIT procedure.
For the secondary endpoint: wear-time field trial session 2 compares REAR initial FIT device with the same FIT device after the trial.
Analvsis results:
Table 4 shows the averaged differences in REAR between initial FIT device versus the same FIT device after the trial. The point estimate of the effect is -0.22 (both ears combined). The 95% confidence interval for the difference in both ears was (-0.87, 0.42). The non-inferiority margins are -5 dB and 5dB.
Conclusion:
After the wear-time field session 2, the REAR outcomes after the Initial FIT procedure are similar to the REAR outcomes using the FIT after the trial. Non-inferiority is demonstrated.
Safety Evaluation:
All participants were free from ear infections, pain or discomfort, acute or chronic dizziness, and no sudden onset or rapid deterioration of tinnitus in one or both ears during baseline screening and wearing hearing aids. No adverse events were reported during the clinical trial.
29
Clinical Data Study Conclusion
The clinical data from this study demonstrates the effectiveness of the self-fitting strategy and satisfies the special controls for the self-fitting hearing aid regulation. Participants experienced noninferior outcomes with self-fitting compared to clinician fitting of the subject device.
10. Non-Clinical Performance Testing
Technological Similarities
The Sontro® Self-Fitting OTC Hearing Aids and predicate device (K211008) share the following technological similarities:
30
Table 5 Soundwave Hearing conducted Non-Clinical Performance Testing on the Sontry® Self-Fitting OTC Hearing Aids to
provide a reasonable assurance of the safety and effectiv
| Test Specifications | Test | Result |
|---|---|---|
| IEC 60601-1:2005 | ||
| (Third Edition) + CORR. | ||
| 1:2006 + CORR. 2:2007 + | ||
| A1:2012 | ||
| ANSI/AAMI ES60601- | ||
| 1:2005 & A1:2012 | ||
| 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 | Electrical Safety: | |
| Rating (clause 4.11) Determination | ||
| of Accessible parts (clause 5.9.2) | ||
| Legibility of markings (cl. 7.1.2) | ||
| Durability of Markings (cl 7.1.3) | ||
| Leakage/Auxiliary current (cl.8. 7, | ||
| IEC 60601-2-66, 201.8.7.2.8) | ||
| Cleaning 11.6.1 (wax removal) | ||
| Detachment /Mechanical pull test IEC | ||
| 60601-2-66 CL. 201.9.2.102 Drop test | ||
| IEC 60601-2-66 201.15.3 | Conforms, Pass | |
| IEC 60601-1-2 2014 + A1:2020 | ||
| Medical electrical equipment part | ||
| 1-2: General requirements for basic | ||
| safety and essential performance- | ||
| Collateral Standard: | ||
| Electromagnetic disturbances - | ||
| requirements and tests | Electromagnetic Compatibility, | |
| EMC | Conforms, Pass | |
| CISPR-11- 2015 + | ||
| A1:2016 | ||
| A2:2019 | ||
| Industrial, scientific, and medical | ||
| equipment-Radio-frequency | ||
| disturbances characteristics- | ||
| Limits and methods of | ||
| measurements | RF Radiated Emissions | Conforms, Pass |
| Test description for CISPR | ||
| Results ANSI C63.10:2013 | Requirements: | Result |
| 6dB Bandwidth | ||
| 99% Bandwidth | ||
| Output Power | ||
| Power Spectral Density | ||
| Low Band Edge | ||
| Duty Cycle Correction Factor | ||
| EIRP | FCC 15C 15.247 ISED RSS-247 | All Tests - Confirm/Pass |
| IEC 61000-4-2 | Electrostatic Discharge (ESD) | Conforms/ Pass |
| IEC 61000-4-3 | Radiated Immunity Test | Conforms/ Pass |
| IEC 61000-4-8 | Magnetic Field Immunity | Conforms/ Pass |
| IEC 60118-7 | Electro acoustical testing | Conforms/ Pass |
| IEC 61000-4-6 - ***The subject | ||
| devices are battery-operated and do | ||
| not have a connection via | ||
| cable. | Required for devices connected to | |
| a cable, does not apply | N/A | |
| ANSI S3.22 | Electro acoustical | Result |
| Special Control 2 ANSI/CTA | ||
| 2051-2017 and underlying ANSI | ||
| S3.22-2014 | Electroacoustic Characteristics | Conforms/ Pass |
| ANSI/ASA S3.22-2014 (6.8) | Frequency Response (Gain) | Conforms/ Pass |
| ANSI/CTA 2051:2017(4.1) with | ||
| underlying test method ANSI | ||
| S3.22:2014 (6.9) | Electro Acoustic -frequency | |
| Response Bandwidth | Conforms/ Pass | |
| ANSI S3.22:2014 (6.2) | Acoustic Output dB Sound Pressure | |
| Level at input 90 db Sound pressure | ||
| Level (OSPL 90) | Conforms/ Pass | |
| ANSI S3.22:2014 (6.2) | Maximum Acoustic Output Sound | |
| Pressure Level Input 90dB SPL | ||
| (Max OSPL90) | Conforms/ Pass | |
| ANSI S3.22:2014 | ||
| (6.11) | Harmonic Distortion | |
| (Output Distortion) | Conforms/ Pass | |
| ANSI S3.22:2014 | ||
| (6.12) | Equivalent Input Noise | |
| (EIN) | Conforms/ Pass | |
| ANSI/CTA 2051:2017 (4.8) | Latency | Conforms/ Pass |
| ANSI S3.22:2014 (6.3) | High Frequency Average Output | |
| Sound Pressure Level | ||
| (HFA OSPL 90) | Conforms/ Pass | |
| ANSI S3.22:2014 (6.5) | High Frequency Average Full on | |
| Gain (HFA FOG) | Conforms/ Pass | |
| ANSI S3.22:2014 (6.7) | Reference Test Gain (RTG) | Conforms/ Pass |
| ANSI/CTA 2051:2017 (4.10 – | ||
| 4.17) | Fixed or Level-Dependent | |
| Frequency Equalization Level |
- Dependent
Gain/Compression
Noise reduction Signal
to Noise Ratio
Enhancement
Feedback Control
Personalization
Coupling to the Ear
Wireless Connectivity | Conforms/ Pass |
| Performance Data:
Subject Device Designed in
Conformance with Standards | | |
| ISO 14971:2019 | Application of Risk management
to Medical Devices | Conforms |
| IEC 62366-1:2015 | Software- Medical Device
Software- Software Life-Cycle
Processes | Conforms |
| IEC 62304:2006+ A1:2015 | Software- Medical Device
Software- Software Life-Cycle
Processes | Conforms |
| Spurious Radiated Emissions
| High Band Edge | |
|---|---|
| IEC 60601 | Electromagnetic Immunity |
| Result |
31
32
33
ANSI/ ASA S3.22 2014 Measurements Comparison
| Table 6 To prove substantial equivalence with the predicate device, Soundwave Hearing evaluated the ANSI S3.22 data set from the predicate (K211008) devices' ANSI/ASA 3.2 |
|---|
| measurements to establish substantial equivalence in acoustic performance. |
| Test Standard /
Method | Test Purpose
Description | Sontro® Self-Fitting OTC Hearing
Aid (Subject Device) | Bose Hearing Aid (Predicate Device) | Discussion |
|----------------------------------------------------------------------------------|------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Special Control 2
ANSI/CTA 2051-
2017 and
underlying ANSI
S3.22-2014 | Electroacoustic
Characteristics | Frequency range: 200-8000 Hz.
Maximum output (90 dB SPL input):
112 dB SPL.
Equivalent noise input level: 25dB
HFA Full-On-Gain (50 dB SPL input):
42 dB
Latency: Difference While the subject FOG value
of 42 dB is greater than the predicate's 30
dB this ensures that our device has the
ability to meet the same gain requirements
once fitted as the predicate even though
the user may not need more amplification
prescribed by NAL-NL2. Data from a
clinical validation study supported
substantial equivalence. |
| ANSI S3.22:2014
(6.7) per
K211008 | Reference Test Gain
(RTG) | 27 dB | 29 dB | Similar to the predicate. Adequate for
fitting mild to moderate hearing loss as
prescribed by NAL-NL2. Data from a
clinical validation study supports
substantial equivalence. |
| ANSI/CTA
2051:2017 (4.10
4.17) per
K211008 | Fixed or Level-
Dependent
Frequency
Equalization | level-dependent frequency equalization
that is adjusted via user controls. | utilize 12-channel wide dynamic range
compression to make conversation
easier without making loud sounds too
loud. | Similar to the predicate. Adequate for
fitting mild to moderate hearing loss as
prescribed by NAL-NL2. Data from a
clinical validation study supports
substantial equivalence. |
| | Level-Dependent
Gain/Compression | utilize 16-channel wide dynamic range
compression to make conversation
easier without making loud sounds too
loud. | utilize 12-channel wide dynamic range
compression to make conversation
easier without making loud sounds too
loud. | Similar to the predicate. Adequate for
fitting mild to moderate hearing loss as
prescribed by NAL-NL2. Data from a
clinical validation study supports
substantial equivalence. |
| Noise Reduction | make steady noises (like vacuum
cleaners, air conditioners, etc.) less
loud. | make steady noises (like vacuum
cleaners, air conditioners, etc.) less
loud. | The Same as the predicate. | |
| Signal-to-Noise
Ratio Enhancement | have user-selectable directional
microphones to emphasize sounds
from in front, making conversations in
noisy places easier. | have user-selectable directional
microphones to emphasize sounds
from in front, making conversations in
noisy places easier. | The Same as the predicate. | |
| Feedback Control | reduce feedback (whistling). | reduce feedback (whistling). | The Same as the predicate. | |
| Personalization | are self-tuned by the user either via an
app on a smart device (phone or tablet)
Individual hearing thresholds are
determined via an in situ hearing test to
personalize the amplification settings. | are self-tuned by the user either via an
app on a smart device (phone or tablet)
or by using the on-device controls.
Individual hearing thresholds are not
required to personalize the
amplification settings. | Similar to the predicate. Adequate for
fitting mild to moderate hearing loss as
prescribed by NAL-NL2. Data from a
clinical validation study supports
substantial equivalence. | |
| Coupling to the Ear | have a user-adjustable fit for greater
comfort and better sound quality.
The ear tip is a soft, conical, open, or
closed tip that rests deep in the ear
canal. | have a user-adjustable fit for greater
comfort and better sound quality.
The ear tip is a soft, conical, open, or
closed tip that rests deep in the ear
canal. | The Same as the predicate. | |
| Wireless
Connectivity | use Bluetooth technology to control
the hearing aids via a paired smart
device. | use Bluetooth technology to control the
hearing aids via a paired smart device. | The Same as the predicate. | |
35
36
37
38
39
Image /page/39/Figure/0 description: The figure shows a frequency response curve, labeled as "Full On Gain (FOG50)". The x-axis represents frequency in Hertz (Hz), ranging from 100 to 10000, while the y-axis represents output in dB SPL, ranging from 0 to 60. The curve shows a relatively flat response between 100 Hz and 1000 Hz, followed by a peak around 2000 Hz, and then a drop-off at higher frequencies. The text at the bottom indicates that the curve represents the nominal frequency response as measured in a 2 cc coupler.
Figure 1 Nominal Frequency Response Curve for Sontro Self-FittingOTC Hearing Aids Full on Gain (FOG50)
Image /page/39/Figure/2 description: The figure shows a plot of the full-on gain (FOG50) in decibels (dB) as a function of frequency in Hertz (Hz). The x-axis represents the frequency, ranging from 100 Hz to 10000 Hz. The y-axis represents the gain, ranging from 0 dB to 50 dB. The plot shows that the gain is around 23 dB at 100 Hz, increases to around 30 dB at 300 Hz, remains relatively constant until 2000 Hz, and then increases to a peak of around 35 dB at 3000 Hz before decreasing to around 16 dB at 10000 Hz.
Image /page/39/Figure/3 description: The image shows the title of a figure. The title is "Figure 2 Nominal Frequency Response Curve for Predicate (K211008) Full On Gain (FOG50)". The title indicates that the figure is a graph that shows the frequency response of a predicate with a specific code and gain setting. The figure is labeled as Figure 2.
Image /page/39/Figure/4 description: This image is a graph titled "Maximum Output (OSPL90)". The graph shows the output in dB SPL on the y-axis and the frequency in Hz on the x-axis. The curve on the graph shows that the maximum output is around 110 dB SPL at a frequency of 100 Hz, and then it gradually decreases to around 90 dB SPL at a frequency of 10000 Hz. The graph is labeled as "Nominal OSPL curve as measured in a 2 cc coupler".
Image /page/39/Figure/5 description: The image contains the word "Aid" in a serif font. The word is presented in a simple, straightforward manner. The text is centrally aligned and occupies a significant portion of the image.
Image /page/39/Figure/6 description: The image is a graph titled "Maximum Output (OSPL90)". The x-axis is labeled "Frequency (Hz)" and ranges from 100 to 10000. The y-axis is labeled "Output (dB SPL)" and ranges from 70 to 120. The graph shows a curve that starts at approximately 100 dB SPL at 100 Hz, rises to approximately 107 dB SPL, remains relatively flat until it reaches 1000 Hz, then peaks at approximately 113 dB SPL before decreasing to approximately 92 dB SPL at 10000 Hz.
Figure 4 Nominal OSPL Curve, Maximum Output OSPL90 for Predicate (K211008)
40
Usability Testing
Soundwave conducted a human factors validation test of the Sontro® Self-Fitting OTC Hearing Aids. The usability testing included 17 untrained participants representing the intended user population (individuals 18 years of age or older with perceived mild to moderate hearing impairment).
The test was performed in the participant's homes, representing the intended use environment of the Soundwave Hearing Sontro® OTC Hearing Aids. Each participant performed hands-on use scenarios and knowledge tasks with the Soundwave Hearing Sontro Self-Fitting OTC Hearing Aids, including the otoTune® app, packaging, accessories, and user documentation. All interaction points between the user and the device were tested to validate user needs and the operation of each device component and user interface as a whole.
After the use scenarios and knowledge tasks, the online tests asked open-ended questions to collect participants' subjective assessments of the use safety and usability by the moderator. The Zoom interviews (during covid) focused on topics of particular interest, ease of use of the otoTune app to customize the Sontro Self-Fitting Hearing Aids, and the validation of the user's improved hearing with the Sontro Self-Fitting Hearing Aids. Users were asked to assess their ability to hear more clearly in noisy environments and assess making adjustments to volume, the equalizer, and noise reduction settings in the Control screen.
Data for the usability test was collected through observational data by 1 Zoom call per participant to observe the participant set up the device. Knowledge task data, 2 follow-up user interviews to assess the ability of the user to operate the device with the user manual, quick start guide, labeling on the device itself, and changing and replacing ear domes, wax guards, and receivers. The interviewer recorded this observational and knowledge task data during the testing to include use problems and use errors.
Participants were given four online tests to record and evaluate the knowledge tasks, points of interaction and operational device components. The results of the human factors validation testing were analyzed qualitatively to determine if the design of the device (or the labeling or user training) needs to be modified to reduce the use-related risks to acceptable levels.
Usability Testing indicates that the subject device and app are able to be used correctly for the intended user, uses, and environment.
11. Non-Inferiority Conclusion
The Sontro® Self-Fitting OTC Hearing Aids have the same intended use and fundamental technology as the predicate, Bose SoundControl Hearing Aid (K211008). Similarly, as its predicate, the Sontro® OTC Hearing Aids are a user-fitted wireless air-conduction hearing aid K231550
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intended for use by individuals 18 years or older with perceived mild to moderate hearing impairment.
The differences in technological characteristics between the subject device, Sontro Self-Fitting OTC Hearing Aid, and the predicate device (K21108) do not raise different questions of how safe and effective they are under specified use conditions. No identified hazard requires additional benefit versus risk analysis supporting non-inferiority.
Clinical testing results indicate that the data support our hypothesis that the device's self-fit procedure is non-inferior to the predicate for the hearing aid fitting in a clinical setting for patients with mild to moderate hearing loss. The clinical study showed:
Real-Ear Aided Responses compare after the self-fit procedure and the fitting of the hearing aid by a certified audiologist. Non-inferiority for the differences of the fitting procedures has been established.
The global APHAB scores and the outcomes of the QuickSIN test show that Sontro Self-Fitting OTC Hearing Aids provide benefits in hearing for mild to moderate hearing-impaired individuals. Non-inferiority for the differences of the fitting procedures has been established.
The outcomes of the QuickSIN test are similar after the self-fit procedure and the fitting of the hearing aid by a certified audiologist. Non-inferiority for the differences of the fitting procedures has been established.
No adverse incidences during the use of the hearing aids have been reported during the study.
Sontro Self-Fitting OTC Hearing Aids. as well as the predicate device, are safe and provide use benefits (effective). The self-fit procedure for both devices is non-inferior to the fitting by a certified audiologist.
Non-clinical performance testing based on the ANSI/ASA S3.22 standards demonstrated the Sontro Self-Fitting OTC Hearing Aids are acoustically comparable to the predicate device(K211008). Non-clinical testing has been conducted to confirm that variations in both form factor and software do not compromise the established safety and effectiveness benchmarks set by the predicate device (K211008).
The subject device Sontro Self-Fitting OTC Hearing Aids conformed to/passed all the nonclinical tests and standard evaluations for Electrical Safety, Electromagnetic Compatibility, CISPR RF Radiated Emissions, CISPR ANSI C63.10:2013, Electromagnetic Immunity, Electro acoustical per ANSI S-322 and was designed in conformance with ISO 14971:2019, IEC 62366-1:2015, IEC 62304:2006+ A1:2015.
Results from the usability test indicated that Soundwave Hearing's Sontro® Self-Fitting OTC Hearing Aids Hearing and otoTune app are able to be used correctly by the intended users under the anticipated condition of use. No identified hazard requires additional benefit versus risk analysis in support of non-inferiority for the Sontro Self-Fitting OTC Hearing Aids. K231550
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In summary, the combined evidence from technology equivalence assessments, clinical testing, non-clinical performance testing, EMC testing, and results from usability testing supports the conclusion that the Sontro Self-Fitting OTC Hearing Aids are non-inferior to the predicate device (K211008).
Conclusion
The Sontro® Self-Fitting OTC Hearing Aids are substantially equivalent in intended use and fundamental scientific technology to the Bose SoundControl Hearing Aids (K211008). The Sontro Self-Fitting OTC Hearing Aids are considered as safe and effective as the predicate device for their intended use when used in accordance with the otoTune® app and the Instructions for Use as Self-Fitting OTC Hearing Aids, QUH.