(214 days)
No
The document does not mention AI, ML, or related terms in the device description, intended use, or performance studies. The changes described are related to hardware modifications and software updates for fitting and control, not AI/ML processing of sound.
No
Explanation: The device is a hearing aid that amplifies sound for individuals with hearing loss. While it addresses a health condition, it is not a therapeutic device meant to treat or cure a disease; rather, it is a rehabilitative device designed to improve hearing.
No
Explanation: The device description and intended use clearly state that the Baha 6 Max Sound Processor is a hearing assistance device that processes sound and sends it to the inner ear, bypassing damaged parts of the ear. It is designed to compensate for hearing loss, not to diagnose a medical condition.
No
The device description explicitly states it is an "external sound processor" that converts acoustic sound into mechanical vibrations and is coupled with hardware components like a Softband, SoundArc, abutment, or magnet, which then interact with a surgically placed titanium implant. While it includes fitting software and a smart app, the core medical device is a hardware sound processor.
Based on the provided information, the Cochlear Baha 6 Max Sound Processor is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens, including blood, tissue, and urine, from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
- Device Function: The Cochlear Baha 6 Max Sound Processor is a hearing system that converts acoustic sound into mechanical vibrations and transmits them to the inner ear via bone conduction. It is a therapeutic device designed to improve hearing, not to analyze biological specimens for diagnostic information.
- Intended Use: The intended use clearly states it is for patients with conductive, mixed, or unilateral sensorineural hearing loss to provide sound amplification and bypass damaged parts of the ear. This is a treatment/rehabilitation function, not a diagnostic one.
- Device Description: The description details how the device works to transmit sound, not how it analyzes biological samples.
Therefore, the Cochlear Baha 6 Max Sound Processor falls under the category of a therapeutic medical device, specifically a hearing aid system, and is not an IVD.
N/A
Intended Use / 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 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. 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.
· 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.
Product codes (comma separated list FDA assigned to the subject device)
LXB
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Ear
Indicated Patient Age Range
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.
Intended User / Care Setting
Prescription Use (Part 21 CFR 801 Subpart D)
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 874.3302 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.
0
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
1
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
2
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 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. 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.
· 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.
| 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."
3
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) Summary
| A. Submitter Information | K202048 |
|---|---|
| Submitted by: | Cochlear Americas |
| 10350 Park Meadows Drive | |
| Lone Tree, CO 80124 | |
| On behalf of the manufacturer: | Cochlear Bone Anchored Solutions AB |
| Konstruktionsvägen 14 | |
| SE-435 33 Mölnlycke | |
| Sweden | |
| (Establishment Number 9616024) | |
| Contact: | Krystal Haley, MS |
| Regulatory Affairs Specialist II | |
| Cochlear Americas | |
| khaley@cochlear.com | |
| (303) 264-2527 (o) | |
| (303) 524-6825 (f) | |
| B. Date Prepared | 23-July-2020 |
| C. Device Name and Classification | |
| Device Names | Cochlear Baha 6 Max Sound Processor |
| Cochlear Baha Fitting Software 6 | |
| Cochlear Baha Smart App | |
| Trade/Proprietary Name: | Cochlear Baha 6 Max Sound Processor |
| Cochlear Baha Fitting Software 6 | |
| Cochlear Baha Smart App | |
| Common/Usual Name: | Baha 6 Max Sound Processor |
| Baha Fitting Software 6 | |
| Baha Smart App | |
| Classification Name: | Hearing Aid, Bone Conduction |
| 21 CFR 874.3300, Class II | |
| Classification Panel | Ear, Nose, and Throat |
| Product Code: | LXB |
| D. Predicate Device | |
| Trade/Proprietary Name: | Cochlear Baha 5 Power Sound Processor |
| Cochlear Baha Fitting Software 5 | |
| Cochlear Baha 5 Smart App |
4
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 Processor
Baha Fitting Software 5
Baha 5 Smart App |
|----------------------|-----------------------------------------------------------------------------|
| Classification Name: | Hearing Aid, Bone Conduction
21 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
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.
5
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.
6
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 Processor
Predicate K161123 | Baha 6 Max Sound Processor |
|--------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------|
| System
compatibility | All percutaneous and transcutaneous
Baha systems, including the original
Baha implant (K955713), the BIA300
implant (K100360), the Baha Softband
or headband (K002913), the Baha
SoundArc (K171088) and the Baha
Attract (K131240).
Compatible with accessories that use
GN Hearing wireless communications
protocol. Also Made For iPhone. | Baha 6 Max Sound Processor
has the same system
compatibility with an addition
of compatibility with select
Android phones. |
| Exterior design | LED, program button, volume rocker,
and battery door (which can be
replaced with tamper resistant door) | The Baha 6 Max has a new
LED, program button, tamper
resistant door, and rounder
shape. It does not have a
volume rocker. |
| Battery size and
type | 675 (zinc-air) | 312 (zinc-air) |
| Materials | Made of medical grade plastics and
metals that have been shown to be
biocompatible and safe for human use | Equivalent – There are two
new materials in the Baha 6
Max. All materials are
biocompatible. |
Table 1. Baha 5 Power Sound Processor and the Baha 6 Max Sound Processor Comparison Summary
7
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 Processor
Predicate K161123 | Baha 6 Max Sound Processor |
|--------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Snap Coupling for attachment | The predicate snap coupling is used to
the connect the sound processor to
implant systems. | The snap coupling has the
same function, but it is also
available in a shorter
configuration. |
| Actuator | Electromagnetic
BCDrive I | Electromagnetic
BCDrive II |
| Platform | Ardium | Xidium |
| Basic Signal and
Processing
Features | 17 channel sound analysis
4 user-defined programs and dedicated
listing programs for
Wide-band Dynamic Range
Compression
Active Balanced Directionality
Noise Management II
Dual Track Feedback Manager
Dedicated fitting rationales for mixed
loss, conductive loss, and SSD
2.4 GHz wireless technology
Scene Classifier
Post Auricular Position Compensation
Wireless Fitting
The predicate did not have Impulse
Noise Control | Same
Same
Same
Same with added bilateral
compression
Same
Same
Same
Same
Same
Same
Baha 6 Max Sound Processor
offers Impulse Noise Control,
which reduces the volume of
sudden loud sounds. |
| Remote Firmware
Upgrade | The predicate did not have Remote
Firmware Upgrades | Remote Firmware Upgrade is
available through the Baha
Smart 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.
8
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 Baha
6 Max Sound Processor |
| Programming
interface | Wired and Wireless | Equivalent - BFS 6 is wireless
only. |
| 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 indications
and thresholds | Same |
| | Adjust gain and MPO settings based on
individual preferences | Equivalent - the gain model
was slightly updated for Baha
6 Max Sound Processor. |
| | Configure signal processing features
based on recommendations and
individual preference | Equivalent – BFS 6 offers an
additional Impulse Noise
Reduction feature |
| | Set up to four programs: Every day,
Noise, Outdoor, and Music | Same |
| | Wireless accessories can be paired and
mixed | Equivalent - Wireless
accessories can be paired,
mixed, and fine tuned |
| | Bilateral SP pairing | Same |
| | LED and Beep alert control | Equivalent - there is an
additional LED option for
Baha 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 Max
Sound Processor |
| Compatibility | Available on iOS and Android | Yes |
| Sound Processor
Support Features | Adjust the volume and gain equalizer
(treble, mid, and bass) on SP | Same |
| Sound Processor
Support Features | Pre-set sound suggestions without
noise reduction features | Pre-set sound suggestions with
Noise Reduction and Impulse
Noise Reduction |
| Sound Processor
Support Features | Activate and Control Cochlear
Wireless Accessories | Same |
9
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 sound
processor and activate wireless
streaming | Same |
| | Link a personalized program to
specific locations | Same |
| Information
available with App | View the battery and connection status | Same |
| | View SP information: model, serial
number, firmware version, and
hardware version | Same |
| | View SP usage and data logging | Same |
| | Locate SP | Same |
| Remote Firmware
Upgrade | Does not have Remote Firmware
Upgrades | Remote Firmware Upgrade is
available through the Baha
Smart App for the Baha 6 Max
Sound 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.