(109 days)
Not Found
No
The document does not mention AI, ML, or any related technologies in the device description, intended use, or performance studies. The self-fitting process is described as user-driven parameter selection.
Yes.
The device is intended to compensate for hearing loss, which is a therapeutic purpose.
No
Explanation: The device is described as a hearing aid intended to amplify and transmit sound to compensate for hearing loss, not to diagnose a medical condition. Its purpose is to assist with hearing, and while it has a "self-fitting" function, this is for adjusting sound profiles, not for diagnosing hearing loss.
No
The device description clearly states the system consists of physical hearing aids, a charging case, cables, and other hardware components in addition to the software application.
Based on the provided information, 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 (like blood, urine, or tissue) to detect diseases, conditions, or infections.
- Device Function: The All-Day Clear Slim and All-Day Clear hearing aids are designed to amplify and transmit sound to compensate for hearing loss. They interact with the user's auditory system directly, not by analyzing biological samples.
- Intended Use: The intended use is to compensate for hearing loss by amplifying sound, not to diagnose or detect a medical condition through in vitro testing.
- Device Description: The description details components related to sound amplification, transmission, and user interaction (app, charging case, eartips), not components for analyzing biological samples.
- Performance Studies: The performance studies focus on the effectiveness of the hearing aids in improving hearing (APHAB, QuickSiN) and safety, not on the accuracy of diagnostic tests performed on biological samples.
Therefore, the All-Day Clear Slim and All-Day Clear hearing aids fall under the category of hearing aids, which are medical devices but not IVDs.
N/A
Intended Use / Indications for Use
The All-Day Clear hearing aids are intended for individuals 18 years or older with perceived mild to moderate hearing loss. The intended use of the All-Day Clear hearing aids is to amplify and transmit sound to the ears and hereby compensate for hearing loss. The hearing aids must only be used by the intended person. They should not be used by any other person as they could damage hearing. The charging case is intended to charge the battery of the rechargeable hearing aids. The All-Day Clear App is intended for individuals 18 years or older, to set-up and/or adjust All-Day Clear hearing aids through Android and Apple iOS smartphones.
The All-Day Clear Slim hearing aids are intended for individuals 18 years or older with perceived mild to moderate hearing loss. The intended use of the All-Day Clear Slim hearing aids is to amplify and transmit sound to the ears and hereby compensate for hearing loss. The hearing aids must only be used by the intended person. They should not be used by any other person as they could damage hearing. The charging case is intended to charge the battery of the rechargeable hearing aids. The All-Day Clear App is intended for individuals 18 years or older, to set-up and/or adjust All-Day Clear Slim hearing aids through Android and Apple iOS smartphones.
Product codes (comma separated list FDA assigned to the subject device)
QUH
Device Description
The All-Day Clear Slim ADCS1 hearing aid and All-Day Clear ADC1 hearing aid are self-fitting air-conduction hearing aids. The ADCS1 and ADC1 hearing aids are nearly identical except for minor design differences. The hearing aid system consists of hearing aids for left and right ears, charging case, charging cable with USB-A and USB-C connector, wall plug, a set of eartips (small, medium, and large sizes), cleaning brush, carrying case (for ADCS1 hearing aids alone), and wax guards. The ADCS1 and ADC1 hearing aids are indicated for over-the-counter use.
The end user can self-fit the hearing aid by downloading the All-Day Clear App to their Android or Apple iOS device, pairing the hearing aids to the App, and following a series of guided onboarding steps:
- Instructions on how to wear the hearing aids
- Creation of a sound profile by listening to sample audio in which the user selects parameters for volume and sound clarity
- Selection of sound balance
Once the hearing aids have been set up with a sound profile, the App can continue to be used as a remote control of the hearing aids. For example, the end users can use the App to change the volume or mute the hearing aid microphones (together or independently), switch between different hearing aid sound modes, adjust the volume of a streamed signal, adjust equalizer and wind noise control, and read out the status of the hearing aid charge level.
The ADCS1 and ADC1 hearing aid system provides an alternative optional method of fitting the device by letting the end users purchase "In-Clinic Care Package", where they can have a licensed hearing care professional fit their hearing aids using professional fitting software called "All-Day Clear Fitting Software." All-Day Clear Fitting Software is a component of Sonova's TrueFit 5.3 or higher fitting software which can only be used by a licensed hearing care professional. In both scenarios, the end users can use the App as a remote control of the hearing aid.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Ears
Indicated Patient Age Range
18 years or older
Intended User / Care Setting
Home (Over-The-Counter Use) or with a licensed hearing care professional in a clinic setting.
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Summary of Non-Clinical Tests:
Sonova AG conducted a series of non-clinical performance testing (Electrical Safety, Electromagnetic Compatibility, RF Testing, Biocompatibility, Human Factors and Usability Engineering, Software, Electroacoustic Performance) to demonstrate that the Sonova ADCS1/ADC1 Hearing Aids are as safe and effective as the Bose SoundControl Hearing Aid. All tests passed except for some aspects of Electromagnetic Compatibility (ESD immunity), which were addressed with justification for safety and effectiveness.
Summary of Human Factors / Usability Tests:
- Study Objective: To investigate whether the ADCS1/ADC1 hearing aids and the companion mobile App could be used as intended by adult patients and caregivers in a simulated use environment and to identify any use errors or difficulties.
- Participants: Thirty participants were enrolled (fifteen patients and fifteen caregivers) from the intended demographic of adults with perceived mild to moderate hearing loss and caregivers.
- Methodology: Participants completed tasks in a simulated use environment associated with self-selecting, setting up, and using the ADCS1/ADC1 hearing aids. Device usage was systematically assessed to identify problems, use errors, and close calls. Evaluations included both objective (performance-based) and subjective (user-feedback) assessments.
- Key Results: The study indicated effective self-selection by inexperienced adults with perceived mild to moderate hearing loss and inexperienced caregivers. All 30 participants were able to use the package information to determine if the device was appropriate. The study also demonstrated the safe use of the devices by the target users.
Summary of Clinical Tests:
- Background: Clinical study performed using "HelloGO" hearing aid (re-branded as All-Day Clear Slim) to demonstrate the effectiveness of the self-fitting strategy for adults with mild to moderate hearing impairment compared to a professionally derived fitting. The devices (ADCS1, ADC1, and HelloGO) were concluded to be equivalent.
- Study Endpoints:
- Primary effectiveness endpoint: Non-inferiority of the Abbreviated Profile of Hearing Aid Benefit (APHAB) global benefit score for self-fit devices versus professionally fit devices.
- Secondary effectiveness endpoint: Non-inferiority of the Quick Speech-in-Noise (QuickSiN) test benefit score for self-fit devices versus professionally fit devices.
- Safety endpoint: Tabulation of all adverse events (AEs) and serious adverse events (SAEs).
- Exploratory endpoints: Wearing comfort questionnaire, Net promoter score, Real ear aided response (REAR).
- Participants: A total of 44 participants (19 females, 25 males), average age 68 years (range 22-80). 77.27% were new hearing device users, 22.7% were current owners.
- Study Design: Double-blind, cross-over study. Participants randomized into two treatment sequence groups: 23 for Professional Fit / Self-Fit (A/B) and 21 for Self-Fit / Professional Fit (B/A). A wash-out period of 1-5 days occurred between initial fitting and first home trial. Each home trial lasted 2 weeks.
- Results:
- Primary Effectiveness (APHAB Global Benefit Score): Adjusted mean treatment difference from mixed model was 0.5%, with a 95% CI ranging from -3.4% to 4.4%. After excluding two outliers with unusually high unaided scores, the reanalysis showed an adjusted mean treatment difference of 0.6%, with a 95% CI ranging from -2.919 to 4.742. Non-inferiority was concluded as the lower bound was greater than the non-inferiority margin (-12.5%).
- Secondary Effectiveness (QuickSiN Benefit Score): Adjusted mean treatment difference from mixed model was 0.046 dB SNR, with a 95% CI ranging from -0.597 to 0.688 dB SNR. Re-analysis using Period 1 data resulted in an adjusted mean treatment difference of 0.103 dB SNR, with a 95% CI ranging from -0.867 to 1.074. Non-inferiority was concluded as the lower bound was greater than the non-inferiority margin (-1.8 dB SNR).
- Safety: One non-serious treatment-emergent adverse event reported (ear canal occlusion due to incorrect ear drop use). No serious adverse events. The clinical study demonstrated the devices are as safe as the predicate.
- Exploratory Endpoints:
- Wearing comfort: 93.2% (41/44) completed; majority rated "Comfortable" or "Very Comfortable."
- Net promoter score: 93.2% (41/44) completed; 26.1% categorized as "promoters."
- Real Ear Aided Response (REAR): 97.7% (43/44) completed; average response at 1000, 1600, and 2500 Hz was approximately 3 dB lower for self-fit compared to professionally fit.
- Conclusion: The findings support the non-inferiority of the self-fitting relative to the professional fitting.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- APHAB Global Benefit Score: Non-inferiority concluded when the mean APHAB global benefit score for the self-fitting method was no more than 12.5% below the mean APHAB global benefit score for the professional fit method. Adjusted mean treatment difference: 0.6% (95% CI: -2.919% to 4.742%) (after outlier exclusion).
- QuickSiN Benefit Score: Non-inferiority concluded if the difference was -1.8 dB or higher. Adjusted mean treatment difference: 0.103 dB SNR (95% CI: -0.867 to 1.074).
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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 contains 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.
June 16, 2023
Sonova AG % Philip Won Associate Hymann, Phelps, & McNamara, P.C. 700 13th Street N.W Suite 1200 Washington DC, District of Columbia 20005
Re: K230538
Trade/Device Name: All-Day Clear Slim ADCS1 Hearing Aid. All-Day Clear ADC1 Hearing Aid Regulation Number: 21 CFR 874.3325 Regulation Name: Self-fitting air-conduction hearing aid Regulatory Class: Class II Product Code: QUH Dated: May 19, 2023 Received: May 19, 2023
Dear Philip Won:
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.
1
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 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531 -542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Shuchen Peng -S
Shu-Chen Peng, Ph.D. Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory. ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K230538
Device Name All-Day Clear ADC1 hearing aid
Indications for Use (Describe)
The All-Day Clear hearing aids are intended for individuals 18 years or older with perceived mild to moderate hearing loss. The intended use of the All-Day Clear hearing aids is to amplify and transmit sound to the ears and hereby compensate for hearing loss. The hearing aids must only be used by the intended person. They should not be used by any other person as they could damage hearing. The charging case is intended to charge the battery of the rechargeable hearing aids. The All-Day Clear App is intended for individuals 18 years or older, to set-up and/or adjust All-Day Clear hearing aids through Android and Apple iOS smartphones.
Type of Use (Select one or both, as applicable)
| Owner-Time Home (STTR 201.301-306) | |
|---|---|
| Owner-Time Home (STTR 201.301-306) |
| | Prescription Use (Part 21 CFR 801 Subpart D)
|X | Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Indications for Use
510(k) Number (if known) K230538
Device Name All-Day Clear Slim ADCS1 hearing aid
Indications for Use (Describe)
The All-Day Clear Slim hearing aids are intended for individuals 18 years or older with perceived mild to moderate hearing loss. The intended use of the All-Day Clear Slim hearing aids is to amplify and transmit sound to the ears and hereby compensate for hearing loss. The hearing aids must only be used by the intended person. They should not be used by any other person as they could damage hearing. The charging case is intended to charge the battery of the rechargeable hearing aids. The All-Day Clear App is intended for individuals 18 years or older, to set-up and/or adjust All-Day Clear Slim hearing aids through Android and Apple iOS smartphones.
| Type of Use (Select one or both, as applicable) | ||
|---|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D)
|X Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
510(k) Summary
In accordance with 21 CFR 807.92 the following summary of information is provided:
DATE: JUNE 16, 2023
SUBMITTER:
Sonova AG 28 Laubisruetistrasse Staefa, Zurich 8712 Switzerland
PRIMARY CONTACT PERSON:
Jongho "Philip" Won Associate Hyman, Phelps, & McNamara, P.C. Phone: 202-577-4132 Email: PWon@hpm.com
SECONDARY CONTACT PERSON:
Nelson Hu Senior Regulatory Systems Analyst Phone: +1 226-338-1048 Email: Nelson.Hu@sonova.com
DEVICE NAME AND CLASSIFICATION:
| TRADE NAME: | All-Day Clear Slim ADCS1 hearing aid
All-Day Clear ADC1 hearing aid |
|-----------------------|------------------------------------------------------------------------|
| COMMON/USUAL NAME: | OTC Self-fitting Hearing Aid |
| CLASSIFICATION NAMES: | Self-fitting Air-Conduction Hearing Aid |
| REGULATION NUMBER: | 21 C.F.R. § 874.3325 |
| PRODUCT CODE: | QUH |
| CLASSIFICATION: | Class II |
| REVIEW PANEL: | Ear, Nose, and Throat |
5
PREDICATE DEVICE:
Bose SoundControl Hearing Aid (K211008)
DEVICE DESCRIPTION:
The All-Day Clear Slim ADCS1 hearing aid and All-Day Clear ADC1 hearing aid are self-fitting air-conduction hearing aids. The ADCS1 and ADC1 hearing aids are nearly identical except for minor design differences. The hearing aid system consists of hearing aids for left and right ears, charging case, charging cable with USB-A and USB-C connector, wall plug, a set of eartips (small, medium, and large sizes), cleaning brush, carrying case (for ADCS1 hearing aids alone), and wax guards. The ADCS1 and ADC1 hearing aids are indicated for over-the-counter use.
The end user can self-fit the hearing aid by downloading the All-Day Clear App to their Android or Apple iOS device, pairing the hearing aids to the App, and following a series of guided onboarding steps:
- Instructions on how to wear the hearing aids ●
- Creation of a sound profile by listening to sample audio in which the user selects . parameters for volume and sound clarity
- Selection of sound balance .
Once the hearing aids have been set up with a sound profile, the App can continue to be used as a remote control of the hearing aids. For example, the end users can use the App to change the volume or mute the hearing aid microphones (together or independently), switch between different hearing aid sound modes, adjust the volume of a streamed signal, adjust equalizer and wind noise control, and read out the status of the hearing aid charge level.
The ADCS1 and ADC1 hearing aid system provides an alternative optional method of fitting the device by letting the end users purchase "In-Clinic Care Package", where they can have a licensed hearing care professional fit their hearing aids using professional fitting software called "All-Day Clear Fitting Software." All-Day Clear Fitting Software is a component of Sonova's TrueFit 5.3 or higher fitting software which can only be used by a licensed hearing care professional. In both scenarios, the end users can use the App as a remote control of the hearing aid.
INTENDED USE:
All-Day Clear Slim ADCS1 hearing aid: All-Day Clear Slim hearing aids are intended for individuals 18 years and older with perceived mild to moderate hearing loss.
6
All-Day Clear ADC1 hearing aid: All-Day Clear hearing aids are intended for individuals 18 years and older with perceived mild to moderate hearing loss.
INDICATIONS FOR USE:
All-Day Clear Slim ADCS1 hearing aid: The All-Day Clear Slim hearing aids are intended for individuals 18 years or older with perceived mild to moderate hearing loss. The intended use of the All-Day Clear Slim hearing aids is to amplify and transmit sound to the ears and hereby compensate for hearing loss. The hearing aids must only be used by the intended person. They should not be used by any other person as they could damage hearing. The charging case is intended to charge the battery of the rechargeable hearing aids. The All-Day Clear App is intended for individuals 18 years or older, to setup and/or adjust All-Day Clear Slim hearing aids through Android and Apple iOS smartphones.
All-Day Clear ADC1 hearing aid: The All-Day Clear hearing aids are intended for individuals 18 years or older with perceived mild to moderate hearing loss. The intended use of the All-Day Clear hearing aids is to amplify and transmit sound to the ears and hereby compensate for hearing loss. The hearing aids must only be used by the intended person. They should not be used by any other person as they could damage hearing. The charging case is intended to charge the battery of the rechargeable hearing aids. The All-Day Clear App is intended for individuals 18 years or older, to set-up and/or adjust All-Day Clear hearing aids through Android and Apple iOS smartphones.
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS:
Both the subject device (ADCS1 and ADC1 hearing aids) and the predicate device (Bose SoundControl Hearing Aids) are self-fitting hearing aids indicated for individuals 18 and older with perceived mild to moderate hearing impairment. The same fundamental technology is present in both hearing aids to allow the user to control and customize the device to the user's hearing needs.
Both devices are receiver-in-canal (RIC) hearing aids designed for all-day wear. While there are some technical differences between the Sonova and Bose devices they do not introduce different questions of safety or effectiveness. The key similarities and differences between the Sonova ADCS1/ADC1 hearing aids and the Bose SoundControl hearing aids are summarized in Table 1.
7
| | Sonova ADCS1
Hearing Aids (Subject
Device) | Sonova ADC1 Hearing
Aids (Subject Device) | Bose SoundControl
Hearing Aids
(K211008, Predicate
Device) | Discussion |
|-----------------|--------------------------------------------------|----------------------------------------------|---------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product
Code | QUH | QUH | QDD | Different.
The product code
QUH reflects the
OTC status of the
device, and the
product code QDD
reflects a restricted
direct-to-consumer
device was in use
prior to the passage of
the OTC hearing aid
rule. |
Table 1. Comparison of technical characteristics of Sonova ADCS1/ADC1 hearing aids and Bose SoundControl hearing aids.
8
| | Sonova ADCS1
Hearing Aids (Subject
Device) | Sonova ADC1 Hearing
Aids (Subject Device) | Bose SoundControl
Hearing Aids
(K211008, Predicate
Device) | Discussion |
|--------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended
Use | All-Day Clear Slim
hearing aids are
intended for individuals
18 years and older with
perceived mild to
moderate hearing loss. | All-Day Clear hearing
aids are intended for
individuals 18 years and
older with perceived
mild to moderate
hearing loss. | Bose SoundControl
Hearing Aids are a
pair of user-fitted
wireless air conduction
hearing aids intended
for use by individuals
18 years and older
with perceived mild to
moderate hearing
impairment. | Identical. |
| | Sonova ADCS1
Hearing Aids (Subject
Device) | Sonova ADC1 Hearing
Aids (Subject Device) | Bose SoundControl
Hearing Aids
(K211008, Predicate
Device) | Discussion |
| Indications
For Use | The All-Day Clear Slim
hearing aids are intended for
individuals 18 years or older
with perceived mild to
moderate hearing loss. The
intended use of the All-Day
Clear Slim hearing aids is to
amplify and transmit sound
to the ears and hereby
compensate for hearing loss.
The hearing aids must only
be used by the intended
person. They should not be
used by any other person as
they could damage hearing.
The charging case is
intended to charge the
battery of the rechargeable
hearing aids. The All-Day
Clear App is intended for
individuals 18 years or
older, to set-up and/or adjust
All-Day Clear Slim hearing
aids through Android and
Apple iOS smartphones. | The All-Day Clear hearing
aids are intended for
individuals 18 years or older
with perceived mild to
moderate hearing loss. The
intended use of the All-Day
Clear hearing aids is to
amplify and transmit sound
to the ears and hereby
compensate for hearing loss.
The hearing aids must only
be used by the intended
person. They should not be
used by any other person as
they could damage hearing.
The charging case is
intended to charge the
battery of the rechargeable
hearing aids. The All-Day
Clear App is intended for
individuals 18 years or
older, to set-up and/or adjust
All-Day Clear hearing aids
through Android and Apple
iOS smartphones. | The Bose SoundControl™
Hearing Aids are 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. | Comparable to
predicate. Both
devices are indicated
for individuals 18 years
and older with
perceived mild to
moderate hearing loss.
The ADCS1/ADC1
hearing aids are
intended for the over-
the-counter use. |
| | Sonova ADCS1
Hearing Aids (Subject
Device) | Sonova ADC1 Hearing
Aids (Subject Device) | Bose SoundControl
Hearing Aids
(K211008, Predicate
Device) | Discussion |
| Device
description | Sonova ADCS1 hearing
aids amplify and
transmit sound to the
ears and thereby
compensate for
perceived mild to
moderate hearing loss.
The users can self-fit the
ADCS1 hearing aids
using the All-Day Clear
App by selecting a
Sound Profile in the
App. | Sonova ADC1 hearing
aids amplify and
transmit sound to the
ears and thereby
compensate for
perceived mild to
moderate hearing loss.
The users can self-fit the
ADC1 hearing aids
using the All-Day Clear
App by selecting a
Sound Profile in the
App. | Bose SoundControl
hearing aid is a
wearable sound
amplifying device that
is intended to
compensate for
impaired hearing.
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
device consists of the
hardware, software,
the Bose Hear app, and
accessories. | Comparable to
predicate. Both the
subject and predicate
devices include hearing
aid hardware, software,
and accessories. |
| | Sonova ADCS1
Hearing Aids (Subject
Device) | Sonova ADC1 Hearing
Aids (Subject Device) | Bose SoundControl
Hearing Aids
(K211008, Predicate
Device) | Discussion |
| Battery | Rechargeable battery | Rechargeable battery | Disposable size 312
zinc-air battery | Different. A different
type of battery does
not raise different
questions of safety
and effectiveness.
The battery safety
tests demonstrated
that the subject device
is as safe and
effective as the
predicate devices
with respect to the
battery. |
| | Sonova ADCS1
Hearing Aids (Subject
Device) | Sonova ADC1 Hearing
Aids (Subject Device) | Bose SoundControl
Hearing Aids
(K211008, Predicate
Device) | Discussion |
| Max
OSPL90 | 109 dB SPL | 110 dB SPL | 113 dB SPL | Comparable to
predicate.
The subject device
has a lower Max
OSPL90 than the
predicate device,
indicating that it is as
safe as the predicate
device. A one or four
dB SPL difference of
the Max OSPL90
compared to the
predicate device does
not raise different
questions of
effectiveness as
demonstrated by the
clinical study. |
| | Sonova ADCS1
Hearing Aids (Subject
Device) | Sonova ADC1 Hearing
Aids (Subject Device) | Bose SoundControl
Hearing Aids
(K211008, Predicate
Device) | Discussion |
| High-
frequency
average
(HFA)
OSPL90 | 103 dB SPL | 106 dB SPL | 106 dB SPL | Comparable to
predicate.
Devices are
equivalent in safety
by having an equal or
lower value. A one or
three dB SPL
difference compared
to the predicate
device does not raise
different questions of
effectiveness as
demonstrated by the
clinical study. |
9
10
11
12
13
14
| | Sonova ADCS1
Hearing Aids (Subject
Device) | Sonova ADC1 Hearing
Aids (Subject Device) | Bose SoundControl
Hearing Aids
(K211008, Predicate
Device) | Discussion |
|---------------------------|--------------------------------------------------|----------------------------------------------|---------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| HFA full on
gain (FOG) | 29 dB | 29 dB | 30 dB | Comparable to
predicate.
Devices are
equivalent in safety
by having an equal or
lower value. A one
dB SPL difference
compared to the
predicate device does
not raise different
questions of
effectiveness as
demonstrated by the
clinical study. |
15
| | Sonova ADCS1
Hearing Aids (Subject
Device) | Sonova ADC1 Hearing
Aids (Subject Device) | Bose SoundControl
Hearing Aids
(K211008, Predicate
Device) | Discussion |
|---------------------------------|--------------------------------------------------|----------------------------------------------|---------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Reference
test gain
(RTG) | 26 dB | 29 dB | 29 dB | Comparable to
predicate.
Devices are
equivalent in safety
by having an equal or
lower value. A one or
three dB SPL
difference compared
to the predicate
device does not raise
different questions of
effectiveness as
demonstrated by the
clinical study. |
16
| | Sonova ADCS1
Hearing Aids (Subject
Device) | Sonova ADC1 Hearing
Aids (Subject Device) | Bose SoundControl
Hearing Aids
(K211008, Predicate
Device) | Discussion |
|------------------------------------|------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Frequency
range | 100 – 8,000 Hz | 100 – 5,000 Hz *
*This is the bandwidth
measured with the
method as specified in
ANSI/CTA-2051:2017.
When measured with
the method as specified
in ANSI/ASA S3.22-
2014, the bandwidth for
ADC1 hearing aids is
100 – 10,000 Hz. | 200 – 8,000 Hz | Comparable to
predicate.
Values meet the same
ANSI/CTA-
2051:2017 standard
for “Standard Band”
device. |
| | Sonova ADCS1
Hearing Aids (Subject
Device) | Sonova ADC1 Hearing
Aids (Subject Device) | Bose SoundControl
Hearing Aids
(K211008, Predicate
Device) | Discussion |
| Harmonic
Distortion | THD @ 500 Hz: 0.5%
THD @ 800 Hz: 0.5%
THD @ 1,600 Hz: 1.0%
THD @ 3,200 Hz: 1.0% | THD @ 500 Hz: 1.0%
THD @ 800 Hz: 1.0%
THD @ 1,600 Hz: 1.0%
THD @ 3,200 Hz: 0.5% |