Patient of any age for use with the Baha Softband (or Baha SoundArc. Patients aged 5 and . older for use with the Baha auditory osseointegrated implant system.

Patients who have a conductive or mixed hearing loss and can still benefit from sound amplification. The . pure tone average bone-conduction hearing threshold (measured at 0.5, 1, 2, and 3kHz) should be better than or equal to 55 dB HL.
. Bilateral fitting is intended for patients who meet the above criterion in both ears, with bilaterally symmetric moderate to severe conductive or mixed hearing loss. Symmetrical bone-conduction thresholds are defined as less than a 10 dB average difference between ears (measured at 0.5, 1, 2, and 3 kHz), or less than a 15 dB difference at individual frequencies.

Patients who suffer from unilateral sensorineural deafness in one ear with normal hearing in the other ear . (i.e. Single-sided deadness: SSD). Normal hearing is defined as a pure tone average air-conduction hearing threshold (measured at 0.5, 1, 2, and 3 kHz) of better than or equal to 20 dB HL.

Baha for SSD is also indicated for any patient who is indicated for an air-conduction contralateral routing . of signals (AC CROS) hearing aid, but who for some reason cannot or will not use an AC CROS.

Device Description

The Cochlear Baha bone conduction hearing system provides an alternate solution for patients who may not benefit from an air-conduction hearing aids. Unlike air-conduction hearing aids, the Baha implant system utilizes a natural bone conduction pathway to send sound directly to the inner ear (cochlea), bypassing a damaged outer or middle ear. The Baha bone conduction hearing system has non-surgical and surgical options. For the non-surgical option, the external sound processor, which converts acoustic sound into mechanical vibrations, is securely placed behind the ear with a Baha Softband or Baha SoundArc. For the surgical option, the external sound processor is coupled with an abutment (Baha Connect) or magnet (Baha Attract). The mechanical vibrations travel the abutment or magnet to a small, titanium implant, which is surgically placed into the bone. The titanium implant has an osseointegrated bond with the surrounding bone, allowing transmission of high-quality sound directly to the inner ear.

The updates made to Baha Fitting Software 6 and Baha Smart App add Remote Assist capabilities to the previously cleared Baha Fitting Software 6 and Baha Smart App (K202048). The changes introduced in this 510(k) are specific to the fitting software and smart app, and do not affect the cleared Baha 6 Max Sound Processor, Softband, SoundArc, Baha Connect abutments, Baha Attract magnet, or the BI300 titanium implant. Introduction of Remote Assist does not modify the intended functionality or fundamental operating principles of the bone conduction hearing system.

By introducing Remote Assist, the healthcare professional can:

Communicate in real-time via video, audio, or messaging, and ●
Connect to and remotely adjust the recipient's Baha 6 Max Sound Processor through the . Baha Fitting Software 6 and Baha Smart App interface.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the Cochlear Baha 6 System, specifically focusing on updates to the Baha Fitting Software 6 and Baha Smart App to introduce "Remote Assist" capabilities.

However, the document does not contain the detailed study information typically associated with acceptance criteria and proof of a device meeting those criteria in the context of advanced AI algorithms for medical image analysis or similar diagnostic tools. The device in question is a hearing aid system, and the "Remote Assist" features relate to remote programming and communication, not to complex diagnostic or predictive AI.

Therefore, many of the requested points relying on AI-specific study designs (like MRMC studies, expert consensus for ground truth on large image datasets, training set details, or standalone algorithm performance) are not applicable to this document. The provided text primarily focuses on demonstrating substantial equivalence to a predicate device for regulatory clearance.

Below, I will answer the applicable questions based on the provided text. For those that are not applicable, I will explicitly state so and explain why.

Device: Cochlear™ Baha® 6 System, Cochlear™ Baha® Fitting Software 6, Cochlear™ Baha® Baha Smart App
Regulatory Clearance: K212136

Acceptance Criteria and Device Performance

The document does not explicitly present a table of predetermined "acceptance criteria" in the format of specific quantifiable metrics (e.g., sensitivity, specificity, AUC values) and then report performance against them. Instead, the "performance data" section focuses on demonstrating functional equivalence and safety/effectiveness compared to a predicate device through various testing types.

The implicit acceptance criterion for this 510(k) submission is that the updated device, with its new "Remote Assist" functionalities, is as safe and as effective for its intended uses compared to the predicate Baha 6 System.

Table of Device Performance (Based on provided text's summary of testing):

Performance Aspect	Reported Device Performance (Summary from text)
Functional Equivalence	The updated Baha 6 System, including the updated Baha Fitting Software 6 and Baha Smart App, are functionally equivalent to the cleared Baha 6 System. This was supported by: - Software testing of new features. - Regression testing of existing functionality (component and system level). - Smoke testing. - Functional test cases (e.g., measurements and programs). - Non-functional test cases (e.g., cybersecurity and deployment). - Hazard control verification. - System-level integration, performance, and design analysis tests.
User Needs & Intended Use	Design validation demonstrated compliance of the new features with user needs and intended use.
Usability Verification	Summative usability testing was conducted. Participants completed a series of tasks throughout a Remote Assist session, and feedback was collected. The results of this testing supported the overall conclusion of safety and effectiveness. (Specific quantitative results or measures of usability are not provided in this summary, but the general statement implies successful completion).
Safety and Effectiveness	The updates have been shown to be as safe and as effective for their intended uses compared to the predicate Baha 6 System. This is the overarching conclusion of the submission, based on all the testing and comparisons.

Study Details (Applicable points only)

2. Sample size used for the test set and the data provenance:

Sample Size: The document does not specify a quantitative sample size for any "test set" in terms of number of patients or cases. It mentions "participants" for usability testing, but no number is given. The testing described is primarily software verification and validation, not a clinical trial with a patient-based test set as might be seen for a diagnostic AI.
Data Provenance: Not explicitly stated in terms way data for an AI would be (e.g., country of origin). The testing seems to be internal development and verification. No mention of retrospective or prospective clinical data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not Applicable. This device is a hearing aid system with remote programming capabilities, not a diagnostic tool requiring expert interpretation of medical images or clinical data to establish a "ground truth" for disease states. The "ground truth" for its functionality is based on its engineering specifications, user needs, and established audiological principles.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not Applicable. An adjudication method is typically used in studies involving human readers or multiple experts to resolve discrepancies in ground truth labeling or diagnostic assessments. This type of study design is not described here, as the testing focuses on software functionality, safety, and effectiveness compared to a predicate device.

5. 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:

Not Applicable. An MRMC study is relevant for evaluating the impact of AI on human diagnostic performance (e.g., radiologists reading images with and without AI assistance). This device is not an AI diagnostic tool and its purpose is to provide hearing assistance and remote fitting, not to aid human "readers" in diagnosis or interpretation.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not Applicable/Implicit. The "algorithm" here is the software that facilitates remote programming and communication for a hearing aid. The performance described (functional equivalence, cybersecurity, etc.) is inherently "standalone" in the sense that the software's core functions are tested. However, this is not an AI algorithm performing a diagnostic task without human intervention; it's a software system designed to be used by both clinicians (human-in-the-loop for programming) and patients for control. The testing confirmed the software's ability to perform its intended functions.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

The "ground truth" for this device's performance is its engineering specifications, functional requirements traceability to user needs, and compliance with general safety and performance principles for medical devices. For example, a "ground truth" for a functional test might be "the software successfully adjusted gain by X dB as per the input, and the sound processor responded correctly." This is based on design documents and expected behavior, not external clinical "ground truth" like pathology.

8. The sample size for the training set:

Not Applicable. This device description does not mention the use of machine learning or deep learning algorithms that would require a distinct "training set" of data for model development. The software is programmatic, not primarily data-driven in its learning capacity at the point of clearance.

9. How the ground truth for the training set was established:

Not Applicable. As there's no stated training set for AI/ML, there's no process described for establishing ground truth for such a set.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

September 29, 2021

Cochlear Americas Whitney Alexander Regulatory Affairs Specialist II 10350 Park Meadows Dr Lone Tree, Colorado 80124

Re: K212136

Trade/Device Name: Cochlear Baha 6 System, Cochlear Baha Fitting Software 6, Cochlear Baha Baha Smart App Regulation Number: 21 CFR 874.3300 Regulation Name: Hearing Aid Regulatory Class: Class II Product Code: LXB Dated: July 7, 2021 Received: July 8, 2021

Dear Whitney Alexander:

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.

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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.

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

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Indications for Use

510(k) Number (if known)

K212136

Device Name

Cochlear™ Baha® 6 System

Indications for Use (Describe)

The Cochlear™ Baha System is intended for the following patients and indications for use:

Patient of any age for use with the Baha Softband (or Baha SoundArc. Patients aged 5 and . older for use with the Baha auditory osseointegrated implant system.

Patients who have a conductive or mixed hearing loss and can still benefit from sound amplification. The . pure tone average bone-conduction hearing threshold (measured at 0.5, 1, 2, and 3kHz) should be better than or equal to 55 dB HL.
. Bilateral fitting is intended for patients who meet the above criterion in both ears, with bilaterally symmetric moderate to severe conductive or mixed hearing loss. Symmetrical bone-conduction thresholds are defined as less than a 10 dB average difference between ears (measured at 0.5, 1, 2, and 3 kHz), or less than a 15 dB difference at individual frequencies.

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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Image /page/3/Picture/0 description: The image shows the logo for Cochlear, a company that specializes in hearing solutions. The logo features a stylized, golden-yellow symbol resembling three overlapping, curved shapes, possibly representing sound waves or the cochlea itself. Below the symbol, the company name "Cochlear" is printed in a matching golden-yellow color, and beneath that, the tagline "Hear now. And always" is displayed in a smaller font.

510(k) Summary A. Submitter Information

Submitted by:

Submitted by:	Cochlear Americas10350 Park Meadows DriveLone Tree, CO 80124
On behalf of the manufacturer:	Cochlear Bone Anchored Solutions ABKonstruktionsvägen 14SE-435 33 MölnlyckeSweden(Establishment Number 9616024)
Contact:	Whitney AlexanderRegulatory Affairs Specialist IICochlear Americaswalexander@cochlear.com(303) 264-2153 (o)(303) 524-6825 (f)
B. Date Prepared	7-July-2021
C. Device Name and Classification
Device Names:	Cochlear™ Baha® 6 SystemCochlear™ Baha® Fitting Software 6Cochlear™ Baha® Baha Smart App
Trade/Proprietary Name:	Cochlear™ Baha® SystemCochlear™ Baha® Fitting Software 6Cochlear™ Baha® Baha Smart App
Common/Usual Name:	Cochlear™ Baha® SystemBaha Fitting Software 6Baha Smart App
Classification Name:	Hearing Aid, Bone Conduction21 CFR 874.3300, Class II
Classification Panel:	Ear, Nose, and Throat
Product Code:	LXB
D. Predicate Device
Device Names:	Cochlear™ Baha® 6 SystemCochlear™ Baha® Fitting Software 6Cochlear™ Baha® Baha Smart App

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Image /page/4/Picture/0 description: The image contains the logo for Cochlear, a company that specializes in hearing solutions. The logo features three curved shapes nested together, resembling the inner ear, in a golden color. Below the symbol, the company name "Cochlear" is written in a similar golden hue, with the registered trademark symbol to the right. The tagline "Hear now. And always" is positioned beneath the company name in a smaller font.

Trade/Proprietary Name:	CochlearTM Baha® SystemCochlearTM Baha® Fitting Software 6CochlearTM Baha® Baha Smart App
Common/Usual Name:	Baha 6 SystemBaha Fitting Software 6Baha Smart App
Classification Name:	Hearing Aid, Bone Conduction21 CFR 874.3300, Class II
Classification Panel:	Ear, Nose, and Throat
Product Code:	LXB
510(k):	K202048

E. Purpose of Submission

This Traditional 510(k) seeks clearance for the implementation of Remote Assist via updates made to Baha Fitting Software 6 and Baha Smart App offered by Cochlear Bone Anchored Solutions (CBAS). Together with the Baha 6 Sound Processor, these components make up the Baha 6 System. The Baha Fitting Software 6 is necessary to program the Baha 6 Max Sound Processor, which converts acoustic signals (sound) into electrical signals, which then generates mechanical action (vibration) from the actuator. The vibrations transmit sound transcranially to the auditory system. The Baha Smart App is a smartphone application that allows recipients to monitor and control their sound processor. Implementation of Remote Assist expands Cochlear's Connected Care offerings to enable real-time, more convenient, and less burdensome clinical care for clinicians and recipients.

F. Device Description

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Image /page/5/Picture/0 description: The image contains the logo for Cochlear. The logo consists of a stylized, golden-yellow spiral shape above the word "Cochlear" in a matching golden-yellow color. Below the word "Cochlear" is the tagline "Hear now. And always" in a smaller font, also in golden-yellow.

not affect the cleared Baha 6 Max Sound Processor, Softband, SoundArc, Baha Connect abutments, Baha Attract magnet, or the BI300 titanium implant. Introduction of Remote Assist does not modify the intended functionality or fundamental operating principles of the bone conduction hearing system.

By introducing Remote Assist, the healthcare professional can:

Communicate in real-time via video, audio, or messaging, and ●
Connect to and remotely adjust the recipient's Baha 6 Max Sound Processor through the . Baha Fitting Software 6 and Baha Smart App interface.

G. Intended Use

The Cochlear Baha System uses bone conduction to transmit sounds to the cochlea (inner ear) with the purpose of enhancing hearing. The Baha Fitting Software is used to program a Cochlear Baha Sound Processor and modify hearing profiles in order to provide comfortable and usable gain for Baha System recipients. The Baha Smart App is a software application intended to remotely control and monitor a Baha Sound Processor directly from a smartphone.

H. Indications for Use

The Cochlear™ Baha System is intended for the following patients and indications for use:

Patient of any age for use with the Baha Softband (or headband) or Baha SoundArc. . Patients aged 5 and older for use with the Baha auditory osseointegrated implant system.
Patients who have a conductive or mixed hearing loss and can still benefit from sound . amplification. The pure tone average bone-conduction hearing threshold (measured at 0.5, 1, 2, and 3kHz) should be better than or equal to 55 dB HL.
. Bilateral fitting is intended for patients who meet the above criterion in both ears, with bilaterally symmetric moderate to severe conductive or mixed hearing loss. Symmetrical bone-conduction thresholds are defined as less than a 10 dB average difference between ears (measured at 0.5, 1, 2, and 3 kHz), or less than a 15 dB difference at individual frequencies.
. Patients who suffer from unilateral sensorineural deafness in one ear with normal hearing in the other ear (i.e. Single-sided deadness: SSD). Normal hearing is defined as a pure tone average air-conduction hearing threshold (measured at 0.5, 1, 2, and 3 kHz) of better than or equal to 20 dB HL.
Baha for SSD is also indicated for any patient who is indicated for an air-conduction ● contralateral routing of signals (AC CROS) hearing aid, but who for some reason cannot or will not use an AC CROS.

I. Technological Characteristics and Comparison to Predicate

The updated Baha 6 System, which includes changes to the Baha Fitting Software 6 and Baha Smart App, has the same intended use, the same algorithms for programming the sound processor, the same overall functional characteristics, and the same fundamental operating principles as the predicate Baha 6 System.

Table 1 summarizes a comparison of the technological characteristics of the currently available Baha 6 System (predicate device) with updated Baha 6 System (subject device). Because the

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Image /page/6/Picture/0 description: The image shows the logo for Cochlear, a company that specializes in hearing solutions. The logo features a stylized, abstract representation of the inner ear, depicted in a golden color. Below the graphic is the company name, "Cochlear," also in golden letters, with the registered trademark symbol. Underneath the company name is the tagline, "Hear now. And always."

changes to the system are for the software components, comparison has been included for the fitting software and smart app.

TechnologicalCharacteristic	Baha 6 System (Subject)	Baha 6 System (Predicate)
Compatible SoundProcessor	Baha 6 Max Sound Processor	Same
Connected CareFeatures	• Remote Firmware Updates of SP• Remote programming through smartphone interface to connect BFS and Baha 6 Max SP via the Baha Smart App• Live video, audio, and chat between BFS and Smart App	• Remote Firmware Updates of SP• Remote programming via clinician control of computer with BFS shipped to recipient
Baha Fitting Software 6 Features
Patient Information	Enter and/or acquire patient information	Same
PrescriptionFeatures	• Enter and/or acquire BC Audiograms• Perform in-situ tone audiometry• Perform in-situ feedback measurement• Informs clinician if high background noise is present during BC direct or feedback measurement.• Allows creation of prescription file without connecting sound processor to BFS 6	• Enter and/or acquire BC Audiograms• Perform in-situ tone audiometry• Perform in-situ feedback measurement
Fitting Features	• Prescribe based on individual indications and thresholds• Adjust gain and MPO settings based on individual preferences• Configure signal processing features based on recommendations and individual preference• Set up to four programs: Every day, Noise, Outdoor, and Music	Same
Saving the session	Store the fitting session to the sound processor, the PC hard drive, or to a network location	Same
TechnologicalCharacteristic	Baha 6 System (Subject)	Baha 6 System (Predicate)
Software Level ofConcern	Minor	Same
Control SoundProcessor Features	• Adjust the volume on sound processor	Same
	• Adjust gain equalizer (treble, mid, and bass) on sound processor
	• Choose from pre-set sound suggestions, which can enable Noise Reduction and Impulse Noise Reduction
	• Change programs on the sound processor
	• Link a personalized program to specific locations
WirelessAccessoriesfeatures	• Control Cochlear Wireless Accessories• Activate wireless streaming	Same
Informationavailable within theapp	• View the battery and connection status• View sound processor usage and data logging• sound processor information:◦ model◦ serial number◦ firmware version◦ hardware version	Same
Device Registration	Capability to register sound processor to user's Cochlear account	Not completed within app
Software Level ofConcern	Minor	Same

Table 1: Comparison summary of Baha 6 System

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Image /page/7/Picture/0 description: The image shows the logo for Cochlear, a company that specializes in hearing solutions. The logo features three curved shapes stacked on top of each other, resembling an ear. Below the symbol is the company name, "Cochlear," in a bold, sans-serif font. Underneath the name is the tagline, "Hear now. And always."

The above changes to the Baha 6 System results in software with added functionalities, primarily additional remote programming capabilities, compared to the predicate system. By implementation of these additional capabilities, Cochlear can expand its Connected Care Services portfolio to provide both clinicians and recipients a more streamlined and improved user experience.

J. Performance Data

Bench testing was conducted to compare the updated Baha 6 System with the cleared Baha 6 System. Substantial equivalence to the predicate system was demonstrated through verification

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Image /page/8/Picture/0 description: The image contains the logo for Cochlear, a company that specializes in hearing solutions. The logo features a stylized, golden-yellow symbol resembling three overlapping sound waves or cochlear shapes. Below the symbol, the company name "Cochlear" is written in a bold, sans-serif font, with the registered trademark symbol (®) next to it. Underneath the company name, the tagline "Hear now. And always" is displayed in a smaller, lighter font.

and validation testing. Verification activities included software testing of new features and regression testing of existing functionality at both the component and system level. Smoke testing, functional test cases (e.g., measurements and programs), non-functional test cases (e.g., cybersecurity and deployment) and hazard control verification were completed. At the system level, integration, performance, and design analysis tests were run.

Validation activities included design validation and summative usability testing. The completed design validation demonstrates compliance of the new features with user needs and intended use. In the usability testing, participants were asked to complete a series of tasks throughout a Remote Assist session, and feedback was collected afterwards.

The testing results demonstrate the updated Baha 6 System, including the updated Baha Fitting Software 6 and Baha Smart App, are functionally equivalent to the cleared Baha 6 System.

K. Conclusion

Based on the indications for use, technological characteristics, substantial equivalence comparison to the predicate device, and performance data, implementation of Remote Assist via updates made to Baha Fitting Software 6 and Baha Smart App, which are the software components of the Baha 6 System, have been shown to be as safe and as effective for their intended uses compared to the predicate Baha 6 System.

Regulation Number and Section

§ 874.3302 Bone-conduction hearing aid.

(a)
Identification. A bone-conduction hearing aid is a wearable sound-amplifying device intended to compensate for impaired hearing and that conducts sound to the inner ear through the skull. The non-implantable components of a bone-conduction hearing aid, such as the external sound processor, are subject to the requirements in § 801.422 of this chapter.(b)
Classification. Class II.