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).

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.

AI/ML Overview

The provided text is a 510(k) Summary for the Bose SoundControl Hearing Aids (K211008). It describes the device, its intended use, and the studies conducted to demonstrate its substantial equivalence to a predicate device (Bose Hearing Aid, DEN180026).

However, the document does not provide specific acceptance criteria or an explicit "study that proves the device meets the acceptance criteria" in the format of a clinical trial report with defined endpoints and statistical analysis. Instead, it argues for substantial equivalence primarily through comparison to a well-established predicate device and various non-clinical and human factors testing.

It states: "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." but does not enumerate these criteria beyond the test names.

Let's break down what information is available and what is missing based on your request.

Acceptance Criteria and Device Performance

The document doesn't explicitly state quantitative acceptance criteria for clinical performance of the Bose SoundControl Hearing Aids, but rather bases its claims on "substantial equivalence" to a predicate device and adequacy for fitting mild to moderate hearing loss. The "results" section primarily refers to "Pass" for various engineering and safety tests.

It also highlights the outcomes of a clinical study for the predicate device, stating it resulted in "outcomes not in any way inferior to professional fitting for adults with mild to moderate hearing loss" and that "subjects in the Self-Fit Group were satisfied with and preferred their own self-adjusted settings to the professionally-selected settings." This is then extrapolated to the new device because the self-fitting method is the same.

A table summarizing the comparison to the predicate device's ANSI S3.22 data is provided, which serves as a form of acceptance criteria (i.e., being "Same" or "Adequate").

Table of Acceptance Criteria (Implied) and Reported Device Performance

Test/Characteristic	Acceptance Criteria (Implied for Substantial Equivalence)	Reported Device Performance (Bose SoundControl Hearing Aids)	Discussion/Predicate Performance
Electrical Safety	Pass (per IEC 60601-1, IEC 60601-2-66, IEC 60601-1-11)	Pass	Satisfied requirements
Electromagnetic Compatibility (EMC)	Pass (per IEC 60601-1-2)	Pass	Satisfied requirements
Electroacoustic Performance	Pass (per ANSI/ASA S3.22 2014)	Pass	Satisfied requirements
Usability Engineering	Pass (per Bose-specified procedure, IEC 60601-1-6)	Pass	Safe and effective for intended users, uses, and environments
Biocompatibility	Pass (per ISO 10993-1, ISO 10993-5, ISO 10993-10)	Pass	Satisfied requirements
Software	Pass (per IEC 62304)	Pass	Satisfied requirements
Max OSPL90	Equivalent to predicate (115 dBSPL), or adequate for fitting moderate hearing loss.	113 dBSPL	"Same" as predicate (115 dBSPL)
HFA OSPL90	Adequate for fitting moderate hearing loss (55 dBHL) as prescribed by NAL-NL2.	106 dBSPL	Predicate: 112 dBSPL. Considered "Adequate"
HFA FOG	Adequate for fitting moderate hearing loss (55 dBHL) as prescribed by NAL-NL2.	30 dB	Predicate: 43 dB. Considered "Adequate"
RTG	Adequate for fitting moderate hearing loss (55 dBHL) as prescribed by NAL-NL2.	29 dB	Predicate: 36 dB. Considered "Adequate"
Frequency Response	Equivalent to predicate's range.	<200 - 8000 Hz	"Same" as predicate (<200 - >8000 Hz)
Harmonic Distortion	Equivalent to predicate's levels.	<1%	Predicate: 3.6%. Considered "Same" (improved)
EIN (Equivalent Input Noise)	Equivalent to predicate's levels.	<27 dBSPL	Predicate: 26 dBSPL. Considered "Same"
Battery Current	N/A (Predicate was rechargeable)	2.8 mA	Not directly comparable, but a new characteristic for the device.
Amplification for Mild to Moderate HL	Deliver adequate amplification to compensate for mild to moderate hearing loss.	Demonstrated in clinical validation study (Figure 1 REAR match to NAL-NL2 targets).	Assessed for 34 ears with open/closed eartips for N2, N3, S2 audiometric configurations.
Self-Fitting Outcomes (based on predicate study)	Not inferior to professional fitting; user satisfaction/preference for self-adjusted settings.	Bose SoundControl self-fitting method is the same as predicate, so predicate clinical data is applied.	Clinical data from DEN180026 showed non-inferiority to professional fitting, and user satisfaction/preference.

Study Details

The document largely relies on the clinical data from the predicate device (DEN180026) for the "clinical performance" aspect, and describes a human factors validation study for the new device.

Sample size used for the test set and the data provenance:
- Clinical Data (from predicate DEN180026, applied to K211008):
  - "demonstrated that Bose SoundControl Hearing Aids deliver adequate amplification to compensate for mild to moderate hearing loss (Figure 1)." This figure states "REAR was obtained in 34 ears".
  - The original predicate study's sample size is not explicitly stated in this document, but implied by the "not in any way inferior to professional fitting" and "patient satisfaction and preference reports" from the self-fit group.
  - Data Provenance: Not specified, but likely prospective clinical study given the nature of the "not inferior" claim and "patient satisfaction" reports. Country of origin not stated.
- Human Factors Validation Test (for Bose SoundControl Hearing Aids K211008):
  - 20 untrained participants representing the intended user population (individuals 18 years of age or older with perceived mild to moderate hearing impairment).
  - Data Provenance: This would be a prospective study specifically for the K211008 device. Country of origin not stated.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Clinical Data (predicate study): Not explicitly stated how many experts or their qualifications were involved in establishing "professional fitting" as ground truth or assessing outcomes like patient satisfaction. The NAL-NL2 amplification targets are a standardized method, not requiring expert consensus for setting targets, but their application and assessment would involve audiologists.
- Human Factors Validation Test: The concept of "ground truth" doesn't directly apply here in the same medical sense. The study aimed to assess safe and effective use by the intended user (untrained participants) interacting with the device and documentation. The "truth" is whether they could complete tasks safely and effectively.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not specified for any of the studies mentioned.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No, an MRMC study was not done. This type of study (MRMC for AI assistance) is not relevant for a self-fitting hearing aid where the "AI" (self-fitting algorithm) works directly with the user, rather than assisting a human reader in interpreting medical images/data. The focus is on the device's direct performance and user interaction.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- The "standalone" performance here would be the electroacoustic measurements (OSPL90, FOG, RTG, etc.) as measured in a 2cc coupler, which are standard hearing aid performance metrics. These were compared for the Bose SoundControl Hearing Aids to the predicate device.
- The "clinical validation study" demonstrating "adequate amplification" (Figure 1) is also a form of objective performance measurement in ears, but it still relates to the output of the device after self-fitting, rather than a completely isolated algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Clinical Data (Predicate):
  - The ground truth for comparison appears to be "professional fitting" of hearing aids by a hearing care professional. User satisfaction and preference are also forms of outcome data collected.
  - For the "adequate amplification" claim, the NAL-NL2 amplification targets are a well-established, evidence-based prescriptive method in audiology, serving as a "ground truth" for appropriate gain delivery.
- Human Factors Study: The "ground truth" is the safety and effectiveness of user interaction with the device, which is assessed through participants' ability to complete tasks and subjective feedback.
The sample size for the training set:
- Not specified. The document focuses on the validation and testing sets. Details of the training data (if any for the self-fitting algorithm's development) are not provided in this 510(k) summary. The summary states: "Device firmware is derived from the DEN180026 device with minor modifications... Software is derived from the DEN180026 with minor modifications... There has been no change from the Self-Fit technology demonstrated in the predicate device submission." This suggests the core self-fitting technology was established and 'trained' (or developed) as part of the predicate, and not fundamentally changed or re-trained for this new device.
How the ground truth for the training set was established:
- Not specified as the training set and its ground truth establishment are not discussed in this 510(k) summary, likely because the core self-fitting algorithm was inherited from the predicate device.

Summary

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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

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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

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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

Enclosure

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Indications for Use

510(k) Number (if known) K211008

Device Name Bose SoundControl™ Hearing Aid

Indications for Use (Describe)

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)

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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:

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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

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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).

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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	ElectromagneticCompatibility (EMC)	Pass
ANSI/ASA S3.22 2014	Electroacoustic	Pass
Bose-specified procedure, ‘Medical –Usability Engineering Procedure’specifies how to apply human factorsengineering methods to productdevelopment	Usability Engineering	Pass
IEC 60601-1-6: 2010+A1:2013

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Test Standard/ Method	Test Purpose/Description	Result
10993-1:2009/TC 1 2010 AssessmentISO 10993-5 CytotoxicityISO 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 HearingAid(DEN180026)	BoseSoundControlHearing 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 moderatehearing loss (55 dBHL) asprescribed by NAL-NL2
HFA FOG	43 dB	30 dB	Adequate for fitting moderatehearing loss (55 dBHL) asprescribed by NAL-NL2
RTG	36 dB	29 dB	Adequate for fitting moderatehearing loss (55 dBHL) asprescribed by NAL-NL2
Frequencyresponse	Figure 2 (right)	Figure 3 (right)
Frequencyrange	<200 - >8000 Hz	<200-8000 Hz	Same
HarmonicDistortion	3.6%	<1%	Same
EIN	26 dBSPL	<27 dBSPL	Same
Battery current	N/A	2.8 mA	Predicate device wasrechargeable

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Image /page/9/Figure/0 description: The image shows two line graphs related to sound control, likely from Bose SoundControl. The left graph plots frequency in Hz on the x-axis against dBSPL on the y-axis, showing a curve that fluctuates between approximately 110 and 115 dBSPL across the frequency range of 10^2 to 10^4 Hz. The right graph plots frequency in Hz on the x-axis against Gain in dB on the y-axis, displaying two curves: one for '2 cc Coupler Gain' and another for 'REIG', both showing gain values between 30 and 40 dB before dropping off at higher frequencies.

Figure 2: OSPL90 (left panel) and frequency response (right panel, solid line) curves for Bose Hearing Aid as measured in 2cc coupler. Note that these curves represent a single measurement of one unit.

Image /page/9/Figure/2 description: The image contains two line plots that show the output and gain of a system as a function of frequency. The plot on the left shows the output in dB SPL versus frequency in Hz, while the plot on the right shows the gain in dB versus frequency in Hz. In the left plot, the output starts at around 100 dB SPL at 100 Hz, increases to around 106 dB SPL at 1000 Hz, peaks at around 113 dB SPL at around 4000 Hz, and then decreases to around 94 dB SPL at 10000 Hz. In the right plot, the gain starts at around 23 dB at 100 Hz, increases to around 30 dB at 1000 Hz, peaks at around 36 dB at around 4000 Hz, and then decreases to around 16 dB at 10000 Hz.

Figure 3: Nominal OSPL90 (left panel) and frequency response (right panel) curves for Bose SoundControl Hearing Aids as measured in 2cc coupler.

Based on the above information. Bose concludes that the Bose SoundControl Hearing Aids are substantially equivalent to the predicate device Bose Hearing Aid (DEN180026).

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. After the use scenarios and knowledge tasks, the moderator asked open-ended questions to collect participants' subjective assessments of use safety and usability. The test found that the Bose SoundControl Hearing Aids are safe and effective for the intended users, uses, and use environments.

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Substantial Equivalence:

The Bose SoundControl Hearing Aids has the same intended use and fundamental technology as the predicate, the Bose Hearing Aid (DEN180026). In the same manner as its predicate the Bose SoundControl Hearing Aids are a user-fitted wireless air-conduction hearing aid intended for over-the-counter use by individuals 18 years or older with perceived mild to moderate hearing impairment. The change discussed in the submission is about the Bose SoundControl Hearing Aids new form factor. The wearable portion of the device is a familiar RIC design powered by disposable size 312 zinc-air battery. Clinical data proves that the Bose SoundControls Hearing Aids are substantially equivalent to its predicate device in acoustic performance. Non-clinical performance testing has been derived from and conducted to ensure that device form factor change does not impact the basic threshold for safety and effectiveness as established by the predicate DEN180026. Device firmware is derived from the DEN180026 device with minor modifications related to the electronics and smaller footprint. Software is derived from the DEN180026 with minor modifications to the user interface for aesthetic reasons. There has been no change from the Self-Fit technology demonstrated in the predicate device submission. Design verification results demonstrate that the subject device (inclusive of software modifications) has substantially equivalent performance to the predicate.

Conclusion:

The Bose SoundControl Hearing Aids are substantially equivalent in intended use and fundamental scientific technology to the Bose Hearing Aid (DEN180026). The Bose SoundControl Hearing Aids are considered as safe and effective as the predicate device for its intended use when used in accordance with its Instructions for Use.

Regulation Number and Section

§ 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.