(125 days)
No.
The provided text primarily describes the device's intended use, physical components, and performance testing, none of which mention or imply the presence of an AI model, DNN, or ML.
Yes.
The device is intended to treat hearing loss by amplifying sound and sending it to the inner ear, which is a therapeutic function.
No
Explanation: The device is described as a "Sound Processor" and a "bone conduction hearing system" intended for sound amplification. Its purpose is to process and transmit sound to the inner ear, bypassing damaged outer or middle ear structures, not to diagnose a condition.
No
The device description clearly states it is a "Cochlear Baha 7 Sound Processor," which is a physical device that converts acoustic sound into mechanical vibrations. It also refers to surgical and non-surgical options involving implants, abutments, magnets, and sound processors. The performance studies section includes "Bench functionality and performance testing" and "Electromagnetic compatibility testing," which are relevant to hardware validation. While it includes "new fitting software (Baha Fitting Software 7)" and an "updated app (Baha Smart App)," these are clearly described as supporting software for the physical sound processor, not the device itself.
No.
The device is a sound processor designed to assist with hearing, functioning by transmitting sound vibrations to the inner ear. It is not used to examine specimens derived from the human body for the purpose of providing information for diagnosis, monitoring, or screening.
N/A
Intended Use / Indications for Use
The Cochlear Baha 7 Sound Processor is intended for the following patients and indications for use:
- Patient of any age for use with the Baha SoundBand, 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.
Product codes
LXB
Device Description
The Cochlear Baha bone conduction hearing system provides an alternate solution for patients who may not benefit from 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 SoundBand, 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 7 Sound Processor is a firmware variant of the previously cleared Baha 6 Max Sound Processor (K202048). The changes introduced in this 510(k) are specific to the sound processor and accessories, and do not affect the cleared Baha Connect abutments, Baha Attract magnet, the BI300 titanium implant, Baha Softband, or Baha SoundArc. The Baha 7 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 supports Bluetooth LE Audio streaming, which enables compatibility with the new generation wireless accessories from GN Hearing.
The Baha 7 Sound Processor will be supported by a new fitting software (Baha Fitting Software 7), an updated app (Baha Smart App), and a new non-surgical retention option (Baha SoundBand).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Ear, cochlea, skull bone, mastoid region
Indicated Patient Age Range
Patient of any age for use with the Baha SoundBand, 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
Not Found
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
Testing of the Baha 7 Sound Processor and components included biocompatibility, software, electromagnetic compatibility, and bench testing.
- Biocompatibility evaluation and testing demonstrated that the materials, packaging residuals, and the input from the manufacturing process are biocompatible.
- Software testing was performed for the Baha Fitting Software 7 and Baha Smart App. The testing demonstrated that the software supported the clinician fitting and recipient control of the Baha 7 Sound Processor.
- Electromagnetic compatibility testing established that the sound processor did not emit excessive amounts of electromagnetic energy, and that it operated as intended in the presence of interference sources.
- Bench functionality and performance testing included functional and performance testing, hardware and interface testing, reliability and environmental testing, as well as system and subsystem level testing. The bench testing demonstrates that the Baha 7 SP does not result in additional safety or efficacy concerns in comparison to the predicate.
The results demonstrated the Baha 7 Sound Processor is functionally equivalent to the Baha 6 Max Sound Processor.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
FDA 510(k) Clearance Letter - Cochlear Baha 7 Sound Processor
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Doc ID # 04017.07.05
May 29, 2025
Cochlear
Denis Dimartino
Senior Regulatory Affairs Specialist
10350 Park Meadows Drive
Lone Tree, Colorado 80214
Re: K250215
Trade/Device Name: Baha 7 Sound Processor; Baha Fitting Software 7 (P2121898); Baha Smart App (iOS) (P1646054); Baha Smart App (Android) (P1646035); Baha SoundBand
Regulation Number: 21 CFR 874.3302
Regulation Name: Bone-Conduction Hearing Aid
Regulatory Class: Class II
Product Code: LXB
Dated: May 5, 2025
Received: May 5, 2025
Dear Denis Dimartino:
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 (the 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 available 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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K250215 - Denis Dimartino
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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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-devices/device-advice-comprehensive-regulatory-
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K250215 - Denis Dimartino
Page 3
assistance/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,
Shuchen Peng -S
Shu-Chen Peng, Ph.D.
Assistant Director
DHT1B: Division of Dental and ENT Devices
OHT1: Office of Ophthalmic, Anesthesia,
Respiratory, ENT, and Dental Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Enclosure
Page 4
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.
Indications for Use
Submission Number (if known)
K250215
Device Name
Baha 7 Sound Processor;
Baha Fitting Software 7 (P2121898);
Baha Smart App (iOS) (P1646054);
Baha Smart App (Android) (P1646035);
Baha SoundBand
Indications for Use (Describe)
The Cochlear Baha 7 Sound Processor is intended for the following patients and indications for use:
- Patient of any age for use with the Baha SoundBand, 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.
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:
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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.
Page 5
510(k) Summary
A. Submitter Information
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: Denis DiMartino
Senior Regulatory Affairs Specialist
Cochlear Americas
ddimartino@cochlear.com
508-304-4356
B. Date Prepared
24-January-2025
C. Device Name and Classification
Device Names: Cochlear™ Baha® 7 Sound Processor
Cochlear™ Baha® Fitting Software 7
Cochlear™ Baha® Smart App
Cochlear™ Baha® SoundBand
Trade/Proprietary Name: Cochlear™ Baha® 7 Sound Processor
Cochlear™ Baha® Fitting Software 7
Cochlear™ Baha® Smart App
Cochlear™ Baha® SoundBand
Common/Usual Name: Baha 7 Sound Processor
Baha Fitting Software 7
Baha Smart App
Baha SoundBand
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® 6 Max Sound Processor
Cochlear™ Baha® Fitting Software 6
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Cochlear™ Baha® Smart App
Cochlear™ Baha® Softband
Common/Usual Name: Baha 6 Max Sound Processor
Baha Fitting Software 6
Baha Smart App
Baha Softband
Classification Name: Hearing Aid, Bone Conduction
21 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 addition of the Baha 7 Sound Processor to the series of sound processors offered by Cochlear. The Baha 7 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 7 Sound Processor, this 510(k) seeks clearance for the Baha Fitting Software 7 (software that is necessary to program the Baha 7 Sound Processor) the Baha Smart App (a smart phone application that allows recipients to monitor and control their sound processor), and the Baha SoundBand (a non-surgical retention option for the Baha sound processors).
F. Device Description
The Cochlear Baha bone conduction hearing system provides an alternate solution for patients who may not benefit from 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 SoundBand, 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 7 Sound Processor is a firmware variant of the previously cleared Baha 6 Max Sound Processor (K202048). The changes introduced in this 510(k) are specific to the sound processor and accessories, and do not affect the cleared Baha Connect abutments, Baha Attract magnet, the BI300 titanium implant, Baha Softband, or Baha SoundArc. The Baha 7 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
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supports Bluetooth LE Audio streaming, which enables compatibility with the new generation wireless accessories from GN Hearing.
The Baha 7 Sound Processor will be supported by a new fitting software (Baha Fitting Software 7), an updated app (Baha Smart App), and a new non-surgical retention option (Baha SoundBand).
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 7 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 SoundBand, Baha Softband or Baha SoundArc™ and can be used unilaterally or bilaterally.
H. Indications for Use
The Cochlear™ Baha® 7 Sound Processor is intended for the following patients and indications for use:
- Patient of any age for use with the Baha SoundBand, 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.
Technological Characteristics and Comparison to Predicate
The Baha 7 Sound Processor has the same intended use, the same external hardware, similar 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
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cleared under K131240), and will also be backward compatible with the original auditory osseointegrated implant (cleared under K955713).
The primary modifications to the Baha 7 Sound Processor relate to improved connectivity, achieved by the new Dooku3 platform (new firmware). An overview of the new features of the Baha 7 Sound Processor is provided below:
- Bluetooth LE Audio, including Auracast
- Ensure the device supports the future of audio streaming, including broadcasting using Auracast.
- Offers more possibilities to access streamed signals, both in terms of personal audio sharing and location based or local audio sharing.
- Compatibility with the New Wireless Accessories from GN (implementing LE Audio)
- Ensure support for full functionality with the new Wireless Accessories from GN, the TVStreamer+ and Multi-Mic+
- An additional color option to appeal to the pediatric segment.
- New laser etching on the device.
Table 1 summarizes a comparison of the features, functions, and performance data for the Baha 7 Sound Processor and the Baha 6 Max Sound Processor (Predicate device system).
Table 1: Baha 6 Max Sound Processor and the Baha 7 Sound Processor Comparison Summary
| Characteristic | Baha 6 Max Sound Processor | Baha 7 Sound Processor |
|---|---|---|
| System compatibility | All percutaneous and transcutaneous Baha systems, including the original Baha implant with the BA210 (K955713), the BIA300 implant [BI300 implant with the BA300 abutment] (K100360), BA310 abutment, and the Baha Attract (K131240). All non-surgical Baha systems, including the Baha Softband or headband (K002913) and Baha Soundarc (K171088). | Baha 7 Sound Processor has the same system compatibility, with an addition of compatibility with the Baha SoundBand. |
| Made for iPhone Hearing Device ASHA protocol for compatible Android Phones | Similar – Baha 7 has increased compatibility with Bluetooth LE Audio | |
| Compatible with accessories that use the GN Hearing Wireless communications protocol | Similar – Baha 7 introduced support for full functionality with the new Wireless |
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| Characteristic | Baha 6 Max Sound Processor | Baha 7 Sound Processor |
|---|---|---|
| Accessories, the TVStreamer+ and Multi-Mic | ||
| Battery size and type | 312 (zinc-air) | Same |
| Materials | Made of medical grade plastics and metals that have been shown to be biocompatible and safe for human use | Equivalent, with the exception of one new color option available for Baha 7 SP (lavender). |
| Snap Coupling for attachment | The predicate snap coupling is used to the connect the sound processor to implant systems. | Equivalent |
| Actuator | Electromagnetic BCDrive II | Electromagnetic BCDrive II |
| Firmware Platform | Dooku2 (Xidium) | Dooku3 (Rhodium) |
| Basic Signal and Processing Features | 4 user-defined programs, which may use dedicated listing programs for every day, outdoor, noise, and music | Similar, the programs now use streaming |
| Active Balanced Directionality | Same | |
| Noise Management II | Same | |
| Dedicated fitting rationales for mixed loss, conductive loss, and SSD | Same | |
| 2.4 GHz wireless technology | The Baha 7 SP supports additional technology: LE Audio for streaming of audio from smart phones and the wireless accessories to Baha 7 Sound processors BLE based protocol Auracast for streaming of audio from Auracast transmitters | |
| Scene Classifier | Same | |
| Wireless Fitting | Same | |
| Baha 6 Max Sound Processor offers Impulse Noise Control, which reduces the volume of sudden loud sounds. | Same | |
| Remote Firmware Upgrade | Remote Firmware Upgrade is available through the Baha Smart App | Same |
| Software | Baha Fitting Software 6 | Baha Fitting Software 7 |
| Baha Smart App v1.1 | Baha Smart App v1.2 |
This 510(k) submission also includes the Baha Fitting Software 7, Baha Smart App, and Baha SoundBand. The predicate device for Baha Fitting Software 7 is Baha Fitting Software 6, which is used to program the previous generation of Baha sound processors. The predicate device for
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the Baha Smart App is the previous version of the Baha Smart App, which is used with the previous generation of Baha sound processors. The predicate device for the Baha SoundBand is the Baha Softband, which is a similar non-surgical retention item for the sound processors. The Baha Fitting Software 7, the Baha Smart App, and Baha SoundBand are compared to their respective predicate devices in Table 2, Table 3, and Table 4, respectively.
Table 2: Baha Fitting Software 6 and Baha Fitting Software 7 Comparison Summary
| Characteristic | Baha Fitting Software 6 | Baha Fitting Software 7 |
|---|---|---|
| Compatibility | Programs a Baha 6 Max Sound Processor | Programs a Baha 7 Sound Processor |
| Programming Interface | Wireless | Same |
| Functions | Datalogging and FW upgrade functionality | BFS 7 has improved datalogging and FW upgrade functionality. It is intended to improve user experience and has no effect on the safety or clinical performance. BFS 7 also introduces new VerfitLINK and DSL-BCD functions, which are both optional features. |
| 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 | Same | |
| Configure signal processing features based on recommendations and individual preference | Same | |
| Set up to four programs: Every day, Noise, Outdoor, and Music | Same | |
| Wireless accessories can be paired and mixed, and fine tuned | BFS7 allows for support of additional new wireless accessories | |
| Bilateral SP pairing | Same | |
| LED and Beep alert control | Same |
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Table 3: Baha Smart App Comparison Summary
| Characteristic | Baha Smart App v1.1 | Baha Smart App v1.2 |
|---|---|---|
| Compatibility | Supports the Baha 5 and Baha 6 Max Sound Processor | Supports the Baha 5, Baha 6 Max and Baha 7 Sound Processors |
| Available on iOS and Android | Same | |
| Sound Processor Support Features | Adjust the volume and gain equalizer (treble, mid, and bass) on SP | Same |
| Pre-set sound suggestions without noise reduction features | Same | |
| Activate and Control Cochlear Wireless Accessories | The BSA v1.2 version includes support for new Wireless Accessories that are compatible with Baha 7 Sound Processor | |
| Change programs on the sound processor and activate wireless streaming | Same | |
| Link a personalized program to specific locations | Same | |
| Information available within 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 Lost SP | Same | |
| Remote Firmware Upgrade | Update the firmware on the Sound Processor via the Smart App | Same |
Table 4: Baha Softband and Baha SoundBand Comparison Summary
| Characteristic | Baha Softband | Baha SoundBand |
|---|---|---|
| Patient Population | The Baha Softband is intended for Baha Sound Processor recipients of any age, no health conditions specified. | Equivalent. The Baha SoundBand is intended for Baha Sound Processor recipients of any age, no health conditions specified. |
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| Characteristic | Baha Softband | Baha SoundBand |
|---|---|---|
| Operating Principle | The Baha Softband combines an elastic band with a connector disc to which the sound processor is attached. It is available in both unilateral (one connector disc) and bilateral (two connector discs) versions. The Baha Softband is placed around the head with the connector disc(s) positioned behind the ear in the mastoid region. | Similar. The Baha SoundBand combines an elastic band with a connector disc to which the sound processor is attached. The Baha SoundBand is placed around the head with the connector disc(s) positioned behind the ear in the mastoid region. |
| Design | Adjustable soft band available in multiple colors, bilateral and unilateral fitting. | Similar. Flexible textile band with adjustable length. It is available with one or two connector discs (unilateral or bilateral version) which are adjustable on the band. |
| Patient Contacting Materials | Biocompatibility evaluation completed per 10993-1. The materials have been evaluated and concluded biocompatible. | Equivalent, biocompatibility evaluation completed per 10993-1: 2018. The materials have been evaluated and concluded biocompatible. |
| Method of Attachment to Sound Processor | Snap coupling technology | Equivalent |
| Compatible Sound Processors | Supports the Baha 5 and Baha 6 Max Sound Processor | Supports the Baha 5, Baha 6 Max Sound Processor, and Baha 7 Sound Processor |
I. Performance Data
Testing of the Baha 7 Sound Processor and components included biocompatibility, software, electromagnetic compatibility, and bench testing.
- Biocompatibility evaluation and testing demonstrated that the materials, packaging residuals, and the input from the manufacturing process are biocompatible.
- Software testing was performed for the Baha Fitting Software 7 and Baha Smart App. The testing demonstrated that the software supported the clinician fitting and recipient control of the Baha 7 Sound Processor.
- Electromagnetic compatibility testing established that the sound processor did not emit excessive amounts of electromagnetic energy, and that it operated as intended in the presence of interference sources.
- Bench functionality and performance testing included functional and performance testing, hardware and interface testing, reliability and environmental testing, as well as system
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and subsystem level testing. The bench testing demonstrates that the Baha 7 SP does not result in additional safety or efficacy concerns in comparison to the predicate.
The results demonstrated the Baha 7 Sound Processor is functionally equivalent to the Baha 6 Max Sound Processor.
J. Conclusion
Based on the indications for use, technological characteristics, substantial equivalence comparison to the predicate device, and performance data, the Baha 7 Sound Processor and components has been shown to be as safe and effective as the predicate device for its intended use.