(30 days)
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and describes a "self-fitting strategy" based on user input, not AI/ML.
Yes.
Explanation: The device is intended to compensate for impaired hearing, which is a therapeutic function.
No
Explanation: The device is described as a "wearable sound amplifying device that is intended to compensate for impaired hearing" and allows users to "program their hearing aids" based on their needs, without the necessity of a preprogramming or a hearing test. The "Intended Use / Indications for Use" section explicitly states "No preprogramming or hearing test is necessary." This indicates it's a therapeutic device for hearing impairment, not a diagnostic one.
No
The device description explicitly states that the Bose SoundControl Hearing Aids consist of "Novidan Inc. hardware, Bose software, the Bose Hear app, and accessories supplied in the carton." It also details hardware components like microphones, receivers, and batteries.
Based on the provided information, the Bose SoundControl™ Hearing Aids is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to "amplify sound for individuals 18 years of age or older with perceived mild to moderate hearing impairment." This describes a device that provides a therapeutic or assistive function, not a diagnostic one.
- Device Description: The description clearly states it is a "wearable sound amplifying device that is intended to compensate for impaired hearing." This aligns with the function of a hearing aid, which is to improve hearing, not to diagnose a condition.
- Lack of Diagnostic Function: The description does not mention any function related to analyzing biological samples (like blood, urine, or tissue) or performing tests to diagnose a disease or condition. IVD devices are specifically designed for such purposes.
- Classification: The device is classified as a Class II medical device under 21 CFR 874.3325 as a "self-fitting wireless air conduction hearing aid." This classification is for devices that aid hearing, not for in vitro diagnostics.
In summary, the Bose SoundControl™ Hearing Aids is a medical device designed to assist individuals with hearing impairment by amplifying sound. It does not perform any diagnostic tests on biological samples, which is the defining characteristic of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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's hearing needs. No preprogramming or hearing test is necessary. The device is intended for direct-to-consumer sale and use without the assistance of a hearing care professional.
Product codes
QDD
Device Description
Per 21 CFR 874.3325 a self-fitting wireless air conduction hearing aid is a wearable sound amplifying device that is intended to compensate for impaired hearing and incorporates technology, including software, that allows users to program their hearing aids. This technology integrates user input with a self-fitting strategy and enables users to independently derive and customize their hearing aid fitting and settings. Self-fitting wireless air conduction hearing aids are class II medical devices.
The Bose SoundControl Hearing Aids (Model BMD0012) are self-fitting wireless air conduction hearing aids consisting of the Novidan Inc. hardware, Bose software, the Bose Hear app, and accessories supplied in the carton.
Each hearing aid in the pair functions and interacts with the Bose Hear app independently and as a system. The hearing aids are powered by a disposable size 312 zinc-air battery. The hearing aids incorporate microphones for audio input and sound is delivered to the ear via a receiver that can be coupled with open or closed domes. The hearing aids are controlled via on-board button controls and wirelessly via the Bose Hear 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
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Ear
Indicated Patient Age Range
18 years of age or older
Intended User / Care Setting
direct-to-consumer sale and use without the assistance of a hearing care professional.
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
Clinical Data: The results of the clinical study used in DEN180026 provide conclusive evidence that the Bose Self-Fitting method results in outcomes not in any way inferior to professional fitting for adults with mild to moderate hearing loss. Based on patient satisfaction and preference reports, subjects in the Self-Fit Group were satisfied with and preferred their own self-adjusted settings to the professionally-selected settings.
A clinical validation study demonstrated that Bose SoundControl Hearing Aids deliver adequate amplification to compensate for mild to moderate hearing loss.
Because the self-fitting method in the Bose SoundControl is the same as the one used in the DEN180026 device the prior DEN180026 clinical data can be used to show that the Bose SoundControl also results in outcomes not in any way inferior to professional fitting for adults with mild to moderate hearing loss.
Non-clinical Performance Testing: Bose conducted performance testing on the Bose SoundControl Hearing Aids to provide a reasonable assurance of safety and effectiveness of the device as compared to the Bose Hearing Aid (DEN180026). Tests included: Electrical Safety (IEC 60601-1:2005+A1:2012, IEC 60601-2-66:2019, IEC 60601-1-11:2015*), Electromagnetic Compatibility (EMC) (IEC 60601-1-2:2014), Electroacoustic (ANSI/ASA S3.22 2014), Usability Engineering (Bose-specified procedure, IEC 60601-1-6: 2010+A1:2013), Biocompatibility (10993-1:2009/TC 1 2010 Assessment ISO 10993-5 Cytotoxicity ISO 10993-10 Irritation / Sensitization), Software (IEC 62304:2006+A1:2015). All tests passed.
Usability Testing: Bose conducted a human factors validation test (i.e., summative usability test) of the Bose SoundControl Hearing Aids in accordance with FDA 's final guidance, Applying Human Factors and Usability Engineering to Medical Devices, Guidance for Industry and Food and Drug Administration Staff (2016). The human factors validation test included 20 untrained participants representing the intended user population (individuals 18 year of age or older with perceived mild to moderate hearing impairment), each of whom performed hands-on use scenarios and knowledge tasks with the Bose SoundControl Hearing Aids, including the Bose Hear app, accessories, and user documentation. The test found that the Bose SoundControl Hearing Aids are safe and effective for the intended users, uses, and use environments.
Comparison of Technological Characteristics (Bose SoundControl Hearing Aids versus Bose Hearing Aid (DEN180026)):
Max OSPL90: 113 dBSPL (Bose SoundControl Hearing Aids) vs 115 dBSPL (Bose Hearing Aid) - Same
HFA OSPL90: 106 dBSPL (Bose SoundControl Hearing Aids) vs 112 dBSPL (Bose Hearing Aid) - Adequate for fitting moderate hearing loss (55 dBHL) as prescribed by NAL-NL2
HFA FOG: 30 dB (Bose SoundControl Hearing Aids) vs 43 dB (Bose Hearing Aid) - Adequate for fitting moderate hearing loss (55 dBHL) as prescribed by NAL-NL2
RTG: 29 dB (Bose SoundControl Hearing Aids) vs 36 dB (Bose Hearing Aid) - Adequate for fitting moderate hearing loss (55 dBHL) as prescribed by NAL-NL2
Frequency range: 8000 Hz (Bose Hearing Aid) - Same
Harmonic Distortion:
§ 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 logos of the U.S. Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The HHS logo is on the left, featuring a stylized design. To the right of it is the FDA logo, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
June 3, 2021
Bose Corporation Bryn Kieras Regulatory Affairs Program Manager The Mountain Framingham, Massachusetts 01701
Re: K211008
Trade/Device Name: Bose SoundControl Hearing Aids Regulation Number: 21 CFR 874.3325 Regulation Name: Self-fitting air-conduction hearing aid Regulatory Class: Class II Product Code: QDD
Dear Bryn Kieras:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated May 5, 2021. Specifically, FDA is updating this SE Letter to correct the Indications For Use (IFU) form Type of Use from Over-The-Counter Use (21 CFR 801 Subpart C) to Restricted Device (per 21 CFR 801.420 and 21 CFR 801.421).
Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Shu-Chen Peng, Ph.D. OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices, (301) 796-6481, shu-chen.peng@fda.hhs.gov.
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
1
Image /page/1/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. Food & Drug Administration" in blue text.
May 5, 2021
Bose Corporation Bryn Kieras Regulatory Affairs Program Manager The Mountain Framingham, Massachusetts 01701
Re: K211008
Trade/Device Name: Bose SoundControl Hearing Aids Regulation Number: 21 CFR 874.3325 Regulation Name: Self-Fitting Air-Conduction Hearing Aid Regulatory Class: Class II Product Code: QDD Dated: April 1, 2021 Received: April 5, 2021
Dear Bryn Kieras:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
2
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(@tda.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
3
Indications for Use
510(k) Number (if known) K211008
Device Name Bose SoundControl™ Hearing Aid
Indications for Use (Describe)
The Bose SoundControl™ Hearing Aids is intended to amplify sound for individuals 18 years of age or older with perceived mild to moderate hearing impairment. It is adjusted by the user's hearing needs. No preprogramming or hearing test is necessary. The device is intended for direct-to-consumer sale and use without the assistance of a hearing care professional.
Restricted Device (per 21 CFR 801.420 and 21 CFR 801.421).
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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
Image /page/4/Picture/0 description: The image shows the word "BOSE" in a bold, sans-serif font. The letters are black, and the background is white. The word is slightly italicized, and there is a trademark symbol in the upper right corner of the image. The logo is simple and modern.
510(k) SUMMARY - K211008
Applicant: Bose Corporation
Address
The Mountain Rd
Framingham, MA 01701
Contact: Bryn Kieras
Phone: (978) 457-2972
Fax: N/A
Establishment Registration Number: 3003361262
Trade Name: Bose SoundControl Hearing Aids
Common/Usual Name: Self-Fit Wireless Air-Conduction Hearing Aid
Classification Name: Self-Fit Wireless Air-Conduction Hearing Aid
Regulation Number: 874.3325
Product Code: ODD
Classification: Class II
Panel: Ear, Nose, and Throat Devices
Predicate Device: Bose Hearing Aid (DEN180026)
Submitter/510(k) Holder: Bose Corporation
Submission Date: April 1, 2021
Device Description:
Per 21 CFR 874.3325 a self-fitting wireless air conduction hearing aid is a wearable sound amplifying device that is intended to compensate for impaired hearing and incorporates technology, including software, that allows users to program their hearing aids. This technology integrates user input with a self-fitting strategy and enables users to independently derive and customize their hearing aid fitting and settings. Self-fitting wireless air conduction hearing aids are class II medical devices.
The Bose SoundControl Hearing Aids (Model BMD0012) are self-fitting wireless air conduction hearing aids consisting of the Novidan Inc. hardware, Bose software, the Bose Hear app, and accessories supplied in the carton.
5
Image /page/5/Picture/0 description: The image shows the word "BOSE" in a bold, sans-serif font. The letters are black, and the background is white. The word is slightly italicized, and there is a horizontal line extending from the top right corner of the "E". The logo is simple and modern.
Each hearing aid in the pair functions and interacts with the Bose Hear app independently and as a system. The hearing aids are powered by a disposable size 312 zinc-air battery. The hearing aids incorporate microphones for audio input and sound is delivered to the ear via a receiver that can be coupled with open or closed domes. The hearing aids are controlled via on-board button controls and wirelessly via the Bose Hear app (iOS and Android). The controls allow the user to configure parameters, settings, and listening modes.
Intended Use:
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.
Indications for Use:
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.
Self-Selection Labeling:
Self-Selection Labeling had been included in the Bose SoundControl Hearing Aids IFU to mitigate the risk of improper self-selection. Summarized, it addresses:
- Identifying situations in which Bose SoundControl Hearing Aids may help you hear better.
- Identifying situations in which Bose SoundControl Hearing Aids may not be right for the user.
- Identifying criteria that indicate the user should see a hearing professional. ●
- Informing the user that the Bose SoundControl 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.
Special Controls:
The Bose SoundControl Hearing aid conforms to the special controls stated in 21 CFR 874.3325. Bose satisfied these requirements through:
- . Clinical Data
6
Image /page/6/Picture/0 description: The image shows the word "BOSE" in a bold, sans-serif font. The letters are black against a white background. The logo has a trademark symbol on the upper right.
Special 510(k) April 1st, 2021
- Non-Clinical Performance Testing ●
- o Human Factors Validation
- Labeling ●
Comparison of Technological Characteristics:
Both the subject (Bose SoundControl Hearing Aids) and the predicate (Bose Hearing Aid) are self-fit direct-to-consumer 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 contain the same technological characteristics:
- Self-Fit Hearing Aid ●
- Home Healthcare Environment use ●
- Bluetooth ●
- On Device Controls ●
- App (Bose Hear app) ●
- o Software Platform Compatibility (iOS, Android)
Technological differences of the Bose SoundControl Hearing Aids were as follows:
- An updated Form Factor to a traditional RIC style hearing aid ●
- A Replaceable Battery ●
- Removal of Telephony and Streaming
- Removal of Active Noise Reduction (ANR) o
The Bose SoundControl Hearing Aids were evaluated through Clinical and Non-Clinical Performance Testing to demonstrate the substantial equivalence to the predicate device as described in DEN180026.
Clinical Data:
The results of the clinical study used in DEN180026 provide conclusive evidence that the Bose Self-Fitting method results in outcomes not in any way inferior to professional fitting for adults with mild to moderate hearing loss. Based on patient satisfaction and preference reports, subjects in the Self-Fit Group were satisfied with and preferred their own selfadjusted settings to the professionally-selected settings.
A clinical validation study demonstrated that Bose SoundControl Hearing Aids deliver adequate amplification to compensate for mild to moderate hearing loss (Figure 1).
7
Image /page/7/Figure/0 description: The image shows three audiograms labeled N2, N3, and S2, each representing different types of hearing loss. The N2 audiogram indicates a gently sloping mild loss with a PTA4 of 31 dB. The N3 audiogram shows a gently sloping moderate loss with a PTA4 of 46 dB, while the S2 audiogram represents a steeply sloping mild loss with a PTA4 of 49. Each audiogram plots output in dBSPL against frequency in Hz, comparing measured REAR values with NAL-NL2 target values.
Figure 1: Mean (open black symbols) ± 1 standard deviation (error bars) of the real-ear aided response (REAR) measured when matching to NAL-NL2 amplification targets (filled blue symbols) for average conversational speech. REAR was obtained in 34 ears, with open and closed eartips, for three standard audiometric configurations (N2, N3 and S2; Bisgaard et al, 2010) representing mild to moderate hearing loss.
Because the self-fitting method in the Bose SoundControl is the same as the one used in the DEN180026 device the prior DEN180026 clinical data can be used to show that the Bose SoundControl also results in outcomes not in any way inferior to professional fitting for adults with mild to moderate hearing loss.
Non-clinical Performance Testing:
Bose conducted performance testing on the Bose SoundControl Hearing Aids to provide a reasonable assurance of safety and effectiveness of the device as compared to the Bose Hearing Aid (DEN180026). The results are summarized in the table below:
| Test Standard/ Method | Test Purpose/
Description | Result |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------|--------|
| IEC 60601-1:2005+A1:2012 | Electrical Safety | Pass |
| IEC 60601-2-66:2019 | | |
| IEC 60601-1-11:2015* | | |
| IEC 60601-1-2:2014 | Electromagnetic
Compatibility (EMC) | Pass |
| ANSI/ASA S3.22 2014 | Electroacoustic | Pass |
| Bose-specified procedure, ‘Medical –
Usability Engineering Procedure’
specifies how to apply human factors
engineering methods to product
development | Usability Engineering | Pass |
| IEC 60601-1-6: 2010+A1:2013 | | |
8
Image /page/8/Picture/0 description: The image shows the word "BOSE" in a bold, sans-serif font. The letters are black, and the background is white. There is a small circle above and to the right of the letter "E", which is a registered trademark symbol. The logo is simple and recognizable.
| Test Standard/ Method | Test Purpose/
Description | Result |
|----------------------------------------------------------------------------------------------------------|------------------------------|--------|
| 10993-1:2009/TC 1 2010 Assessment
ISO 10993-5 Cytotoxicity
ISO 10993-10 Irritation / Sensitization | Biocompatibility | Pass |
| IEC 62304:2006+A1:2015 | Software | Pass |
*Applicable sections
The range of testing and all acceptance criteria are appropriate to evaluate this device based on its proposed intended use. All acceptance criteria were met.
ANSI/ASA S3.22 2014 Measurements
In order to prove substantial equivalence with the predicate device, Bose evaluated the ANSI S3.22 data set from the predicate (DEN180026) devices ANSI/ASA S3.22 measurements in order to establish substantial equivalence in acoustic performance.
| Test | Bose Hearing
Aid
(DEN180026) | Bose
SoundControl
Hearing Aids | Discussion |
|------------------------|------------------------------------|--------------------------------------|-------------------------------------------------------------------------------------|
| OSPL90 curve | Figure 2 (left) | Figure 3 (left) | |
| Max OSPL90 | 115 dBSPL | 113 dBSPL | Same |
| HFA OSPL90 | 112 dBSPL | 106 dBSPL | Adequate for fitting moderate
hearing loss (55 dBHL) as
prescribed by NAL-NL2 |
| HFA FOG | 43 dB | 30 dB | Adequate for fitting moderate
hearing loss (55 dBHL) as
prescribed by NAL-NL2 |
| RTG | 36 dB | 29 dB | Adequate for fitting moderate
hearing loss (55 dBHL) as
prescribed by NAL-NL2 |
| Frequency
response | Figure 2 (right) | Figure 3 (right) | |
| Frequency
range | 8000 Hz |