· 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 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 system utilizes a natural bone conduction pathway to send sound directly to the inner ear (cochlea), bypassing a damaged outer or midle 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 through 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 Baha 6 Max Sound Processor is a modification of the previously cleared Baha 5 Power Sound Processor (K161123). The changes introduced in this 510(k) are specific to the sound processor and accessories, and do not affect the cleared Softband, SoundArc, Baha Connect abutments, Baha Attract magnet, or the B1300 titanium implant. The Baha 6 Max Sound Processor does not modify the intended functionality or fundamental operating principles of the bone conduction hearing system. The changes within culminate as the next generation Baha sound processor that provides recipients with moderate hearing loss, up to 55 dB, access to sound.

The Baha 6 Max Sound Processor will be supported by a new fitting software, Baha Fitting Software 6, and a new app, Baha Smart App.

AI/ML Overview

The provided text describes the Cochlear Baha 6 Max Sound Processor and associated software (Cochlear Baha Fitting Software 6, Cochlear Baha Smart App) and states that they are substantially equivalent to their predicate devices. However, the document does not describe a study involving acceptance criteria and device performance as requested in the prompt.

The content focuses on a 510(k) summary, which outlines the device's indications for use, technological characteristics, and a comparison to a predicate device (Cochlear Baha 5 Power Sound Processor). It mentions "Performance Data" but only states that "Bench testing was conducted to compare the Baha 6 Max Sound Processor with the Baha 5 Power Sound Processor, including use with the predicate implant / abutment systems." It further states that "Substantial equivalence to the predicate device was accomplished through functionality and performance testing, hardware and interface testing, reliability and environmental testing, as well as system and subsystem level testing." Software verification and validation were also completed.

Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor details about sample sizes, ground truth establishment, expert adjudication, or MRMC studies, as these specific details are not present in the provided text.

The document concludes that based on indications for use, technological characteristics, and performance data (without detailing the data itself or the acceptance criteria), the new device is substantially equivalent to the predicate.

Summary

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Image /page/0/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 is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

February 23, 2021

Cochlear Americas Krystal Haley Regulatory Affairs Specialist II 10350 Park Meadows Drive Lone Tree. Colorado 80124

Re: K202048

Trade/Device Name: Cochlear Baha 6 Max Sound Processor, Cochlear Baha Fitting Software 6, Cochlear Baha Smart App Regulation Number: 21 CFR 874.3300 Regulation Name: Hearing Aid Regulatory Class: Class II Product Code: LXB Dated: January 22, 2021 Received: January 25, 2021

Dear Krystal Haley:

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

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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 (OS) 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 mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/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. Acting Assistant Director DHT1C: Division of ENT, Sleep Disordered Breathing, Respiratory and Anesthesia 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) K202048

Device Name

Cochlear Baha 6 Max Sound Processor, Cochlear Baha Fitting Software 6, Cochlear Baha Smart App

Indications for Use (Describe)

The Cochlear Baha 6 Max Sound Processor 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 suffer from unilateral sensorineural deafness in one ear with normal hearing in the other ear (i.e. Singlesided 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.

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 is a logo for Cochlear, a company that specializes in hearing solutions. The logo features a stylized, golden-yellow spiral shape resembling an ear or sound wave. Below the spiral is the company name, "Cochlear," in a matching golden-yellow color. Underneath the name is the tagline, "Hear now. And always" in a smaller font, emphasizing the company's commitment to long-term hearing solutions.

510(k) SummaryA. Submitter Information	K202048
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:	Krystal Haley, MSRegulatory Affairs Specialist IICochlear Americaskhaley@cochlear.com(303) 264-2527 (o)(303) 524-6825 (f)
B. Date Prepared	23-July-2020
C. Device Name and ClassificationDevice Names	Cochlear Baha 6 Max Sound ProcessorCochlear Baha Fitting Software 6Cochlear Baha Smart App
Trade/Proprietary Name:	Cochlear Baha 6 Max Sound ProcessorCochlear Baha Fitting Software 6Cochlear Baha Smart App
Common/Usual Name:	Baha 6 Max Sound ProcessorBaha 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 DeviceTrade/Proprietary Name:	Cochlear Baha 5 Power Sound ProcessorCochlear Baha Fitting Software 5Cochlear Baha 5 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 a stylized, golden-yellow spiral shape above the company name. Below the name, the tagline "Hear now. And always" is displayed in a smaller font, emphasizing the company's commitment to long-term hearing support.

Common/Usual Name:	Baha 5 Power Sound ProcessorBaha Fitting Software 5Baha 5 Smart App
Classification Name:	Hearing Aid, Bone Conduction21 CFR 874.3300, Class II
Classification Panel	Ear, Nose, and Throat
Product Code:	LXB
510(k):	K161123

E. Purpose of Submission

This Traditional 510(k) seeks clearance for the addition of the Baha 6 Max Sound Processor to the series of sound processors offered by Cochlear Bone Anchored Solutions (CBAS). The Baha 6 Max Sound Processor 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. In addition to the Baha 6 Max Sound Processor, this 510(k) seeks clearance for the Baha Fitting Software 6, software that is necessary to program the Baha 6 Max Sound Processor, and the Baha Smart App, a smart phone application that allows recipients to monitor and control their sound processor.

F. Device Description

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Image /page/5/Picture/0 description: The image contains the logo for Cochlear, a company that specializes in hearing solutions. The logo features a stylized graphic of three curved shapes, resembling the inner ear, stacked on top of each other. Below the graphic, the company name "Cochlear" is written in a bold, sans-serif font. Underneath the company name is the tagline "Hear now. And always" in a smaller, lighter font.

The Baha 6 Max Sound Processor will be supported by a new fitting software, Baha Fitting Software 6, and a new app, Baha Smart App.

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 6 Max Sound Processor is intended to be used as part of the Cochlear Baha System to pick up surrounding sound and transfer it to the skull bone via a Baha Implant, Baha Softband or Baha SoundArc and can be used unilaterally or bilaterally.

H. Indications for Use

The Cochlear Baha 6 Max Sound Processor 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 Baha 6 Max Sound Processor has the same intended use, a similar mechanical design, the same functional characteristics, the same fundamental operating principles, and is made of biocompatible materials like the predicate device.

The modified sound processor is compatible with the currently marketed Softband/headband (cleared under K002913 and letters to file under this clearance), the currently marketed SoundArc (cleared under K171088) and the currently marketed auditory osseointegrated implant (BIA300 system, cleared under K100360, BA400, cleared under K121317, and the Baha Attract cleared under K131240), and will also be backward compatible with the original auditory osseointegrated implant (cleared under K955713).

Like the predicate, the Baha 6 Max Sound Processor has an LED visual indicator and an available tamper resistant battery door. The primary modifications are the introduction of the BC Drive II actuator and the Xidium platform, and optimizations to the hardware.

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Image /page/6/Picture/0 description: The image contains the logo for Cochlear, a company that specializes in hearing solutions. The logo features a stylized, golden-yellow graphic of three curved shapes resembling sound waves or cochlear spirals, stacked on top of each other. Below the graphic is the company name, "Cochlear," in a bold, sans-serif font, also in golden-yellow. Underneath the name is the tagline, "Hear now. And always," in a smaller, lighter font.

The BC Drive II actuator was optimized to be smaller than the actuator in the predicate.
The Xidium platform has improved processing power and lower power consumption than the predicate, contributing to minor changes to the sound processing features.
The hardware was optimized and is now less prone to feedback. Additionally, the sound ● processor is available with either of the following installed: a shorter snap coupling, resulting in a lower profile than the predicate, or an extended snap coupling, with the same profile as the predicate.
. The new sound processor features include improved feedback suppression, impulse noise reduction, and improved directionality for bilateral recipients. The sound processor also has direct audio streaming for iPhone and selected Android phones and the ability to upgrade the firmware remotely.

The above changes resulted in a smaller, lighter sound processor that uses a smaller battery while achieving the same fitting range (55 dB) as the predicate.

Table 1 summarizes a comparison of the features, functions, and performance data for the Baha 6 Max Sound Processor and the Baha 5 Power Sound Processor (predicate device).

Characteristic	Baha 5 Power Sound ProcessorPredicate K161123	Baha 6 Max Sound Processor
Systemcompatibility	All percutaneous and transcutaneousBaha systems, including the originalBaha implant (K955713), the BIA300implant (K100360), the Baha Softbandor headband (K002913), the BahaSoundArc (K171088) and the BahaAttract (K131240).Compatible with accessories that useGN Hearing wireless communicationsprotocol. Also Made For iPhone.	Baha 6 Max Sound Processorhas the same systemcompatibility with an additionof compatibility with selectAndroid phones.
Exterior design	LED, program button, volume rocker,and battery door (which can bereplaced with tamper resistant door)	The Baha 6 Max has a newLED, program button, tamperresistant door, and roundershape. It does not have avolume rocker.
Battery size andtype	675 (zinc-air)	312 (zinc-air)
Materials	Made of medical grade plastics andmetals that have been shown to bebiocompatible and safe for human use	Equivalent – There are twonew materials in the Baha 6Max. All materials arebiocompatible.

Table 1. Baha 5 Power Sound Processor and the Baha 6 Max Sound Processor Comparison Summary

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Image /page/7/Picture/0 description: The image contains the logo for Cochlear, a company that specializes in hearing solutions. The logo features a stylized, golden-yellow graphic of three overlapping, crescent-shaped elements, resembling an ear or sound waves. Below the graphic, the company name "Cochlear" is written in a matching golden-yellow color, and beneath that, the tagline "Hear now. And always" is displayed in a smaller font.

Characteristic	Baha 5 Power Sound ProcessorPredicate K161123	Baha 6 Max Sound Processor
Snap Coupling for attachment	The predicate snap coupling is used tothe connect the sound processor toimplant systems.	The snap coupling has thesame function, but it is alsoavailable in a shorterconfiguration.
Actuator	ElectromagneticBCDrive I	ElectromagneticBCDrive II
Platform	Ardium	Xidium
Basic Signal andProcessingFeatures	17 channel sound analysis4 user-defined programs and dedicatedlisting programs forWide-band Dynamic RangeCompressionActive Balanced DirectionalityNoise Management IIDual Track Feedback ManagerDedicated fitting rationales for mixedloss, conductive loss, and SSD2.4 GHz wireless technologyScene ClassifierPost Auricular Position CompensationWireless FittingThe predicate did not have ImpulseNoise Control	SameSameSameSame with added bilateralcompressionSameSameSameSameSameSameBaha 6 Max Sound Processoroffers Impulse Noise Control,which reduces the volume ofsudden loud sounds.
Remote FirmwareUpgrade	The predicate did not have RemoteFirmware Upgrades	Remote Firmware Upgrade isavailable through the BahaSmart App
Software	Baha Fitting Software 5	Baha Fitting Software 6

This 510(k) submission also includes Baha Fitting Software 6 and Baha Smart App. The predicate device for Baha Fitting Software 6 is Baha Fitting Software 5, which is used to program the previous generation of Baha sound processors. The reference device for the Baha Smart App is the Osia Smart App due to the number of shared features that are not available on the Baha 5 Smart App, which is used with the previous generation of Baha sound processors. The features and functions for the Baha Fitting Software 6 and the Baha Smart App are compared to their respective predicate and reference devices in Table 2 and Table 3 respectively.

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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 graphic of three overlapping, curved shapes, resembling sound waves or a cochlea. Below the graphic is the company name, "Cochlear," also in golden-yellow, with the registered trademark symbol to the right. Underneath the company name is the tagline, "Hear now. And always," in a smaller, lighter font.

Characteristic	Baha Fitting Software 5 Predicate(K161123)	Baha 6 Fitting Software
Compatibility	Programs a Baha 5 Sound Processor	Equivalent – programs a Baha6 Max Sound Processor
Programminginterface	Wired and Wireless	Equivalent - BFS 6 is wirelessonly.
Fitting Features	Enter and/or acquire patient indications	Same
	Enter and/or acquire BC Audiograms	Same
	Perform in-situ tone audiometry	Same
	Perform in-situ feedback measurement	Same
	Prescribe based on individual indicationsand thresholds	Same
	Adjust gain and MPO settings based onindividual preferences	Equivalent - the gain modelwas slightly updated for Baha6 Max Sound Processor.
	Configure signal processing featuresbased on recommendations andindividual preference	Equivalent – BFS 6 offers anadditional Impulse NoiseReduction feature
	Set up to four programs: Every day,Noise, Outdoor, and Music	Same
	Wireless accessories can be paired andmixed	Equivalent - Wirelessaccessories can be paired,mixed, and fine tuned
	Bilateral SP pairing	Same
	LED and Beep alert control	Equivalent - there is anadditional LED option forBaha 6 Max Sound Processor

Table 2. Baha Fitting Software 5 and the Baha 6 Fitting Software Comparison Summary

Table 3. Osia Smart App and the Baha Smart App Comparison Summary

Characteristic	Osia Smart App Reference(K191921)	Baha Smart App
Compatibility	Supports the Osia 2 Sound Processor	Supports the Baha 6 MaxSound Processor
Compatibility	Available on iOS and Android	Yes
Sound ProcessorSupport Features	Adjust the volume and gain equalizer(treble, mid, and bass) on SP	Same
Sound ProcessorSupport Features	Pre-set sound suggestions withoutnoise reduction features	Pre-set sound suggestions withNoise Reduction and ImpulseNoise Reduction
Sound ProcessorSupport Features	Activate and Control CochlearWireless Accessories	Same

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Image /page/9/Picture/0 description: The image contains the logo for Cochlear. The logo consists of three curved shapes stacked on top of each other, resembling an ear. The word "Cochlear" is written in a sans-serif font below the symbol. Underneath the word "Cochlear" is the tagline "Hear now. And always."

Characteristic	Osia Smart App Reference(K191921)	Baha Smart App
	Change programs on the soundprocessor and activate wirelessstreaming	Same
	Link a personalized program tospecific locations	Same
Informationavailable with App	View the battery and connection status	Same
	View SP information: model, serialnumber, firmware version, andhardware version	Same
	View SP usage and data logging	Same
	Locate SP	Same
Remote FirmwareUpgrade	Does not have Remote FirmwareUpgrades	Remote Firmware Upgrade isavailable through the BahaSmart App for the Baha 6 MaxSound Processor

J. Performance Data

Bench testing was conducted to compare the Baha 6 Max Sound Processor with the Baha 5 Power Sound Processor, including use with the predicate implant / abutment systems. Substantial equivalence to the predicate device was accomplished through functionality and performance testing, hardware and interface testing, reliability and environmental testing, as well as system and subsystem level testing. Software verification and validation of Baha Fitting Software 6 and Baha Smart App was also completed to establish that the software are functionally equivalent to their respective predicate and reference devices and support substantial equivalence. The results demonstrated the Baha 6 Max Sound Processor is functionally equivalent to the Baha 5 Power Sound Processor.

K. Conclusion

Based on the indications for use, technological characteristics, and performance data, the Baha 6 Max Sound Processor, Baha Fitting Software 6, and Baha Smart App have been shown to be substantially equivalent in comparison to the predicate device.

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.