Predicate Devices

Reference Devices

K080363, K090720, K110996, K132278, K142907, K153245, K161123

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a mechanical device (SoundArc) that holds existing sound processors. There is no mention of AI or ML in the device description, intended use, or performance studies.

Therapeutic

Yes
The device is described as being for "patients who have a conductive or mixed hearing loss and can still benefit from sound amplification" and "unilateral sensorineural deafness," which clearly indicates an intent to treat or alleviate a medical condition.

Diagnostic

No

The device is described as an accessory for existing Baha sound processors, designed to hold them in place for operation without an implant, primarily for test situations or for patients who choose not to have an implant. It is not intended to provide a diagnosis but rather to facilitate sound amplification for individuals with specific hearing losses.

SaMD (Software as a Medical Device)

No

The device description clearly states it is an "encapsulated spring wire that wraps around the back of the head" and holds a sound processor, indicating it is a physical hardware component, not software.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro (outside the body) for the examination of specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
Device Function: The Cochlear Baha® SoundArc is a device that holds a sound processor against the skull to transmit sound through bone conduction. It is used for hearing amplification and addressing hearing loss.
Intended Use: The intended use clearly describes its purpose in addressing hearing loss and providing sound amplification, not for analyzing biological specimens.
Device Description: The description details a physical device that wraps around the head and holds a sound processor, not a test kit or instrument for analyzing samples.

The device is a medical device, but it falls under a different category than In Vitro Diagnostics. It is a device used to aid hearing, not to diagnose a condition by analyzing biological samples.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Cochlear Baha® SoundArc is intended for test situations and for patients who cannot or choose not to have an implant for the following indications for use:

· Patients of any age who have a conductive or mixed hearing loss and can still benefit from sound amplification. The pure tone average bone-conduction hearing thressured at 0.5, 1, 2, and 3kHz) should be better than or equal to 45 dB HL for use with the BP100, Baha 4 and Baha 5 sound processors, 55 dB HL for use with the BP110 Power and Baha 5 Power sound processors, and better than or equal to 65 dB HL for use with the Cordelle II and Baha 5 SuperPower Sound Processors.

· 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-conductive thresholds are defined as 10 dB average difference between ears (measured at 0.5, 1,2, and 3 kHz), or less than a 15dB difference at individual frequencies.

· Patients who suffer from unilateral sensorineural deafness in one ear with normal hearing in the other ear (i.e. Singlesided deafness: SSDTM). 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

Baha SoundArc is an encapsulated spring wire that wraps around the back of the head and sits behind and above the ears. SoundArc is designed with a symmetrical disc holder that holds the Baha sound processor in place, and is compatible with existing Baha sound processors. The design of SoundArc enables the Baha device to be placed against the skull for operation without the need for a Baha implant to be placed.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

mastoid, ears, skull

Indicated Patient Age Range

Patients of any age

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 (study type, sample size, AUC, MRMC, standalone performance, key results)

Performance testing was conducted based on a comparison between the proposed SoundArc and the legally marketed Softband and the current Baha sound processors of the predicate Baha system. Substantial equivalence to the predicate system was accomplished through functional and performance tests, design and specification analysis, and biocompatibility evaluation. The results demonstrated the Baha SoundArc is functionally equivalent to the predicate system.

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.

K002913

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.

K080363, K090720, K110996, K132278, K142907, K153245, K161123

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

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.

Summary

0

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing to the right, stacked on top of each other. The profiles are black and are arranged to create a sense of depth. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circle around the profiles.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - W O66-G609 Silver Spring, MD 20993-0002

Cochlear Americas Beth Murray Senior Regulatory Affairs Specialist 13059 E. Peakview Avenue Centennial, CO 80111

June 7, 2017

Re: K171088

Trade/Device Name: Cochlear™ Baha® SoundArc Regulation Number: 21 CFR 874.3300 Regulation Name: Hearing Aid Regulatory Class: Class II Product Code: LXB Dated: May 12, 2017 Received: May 15, 2017

Dear Beth Murray:

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. The general controls provisions of the Actinclude 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.

1

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Eric A. Mann -S

for Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

2

Indications for Use

510(k) Number (if known) K171088

Device Name Cochlear Baha® SoundArc

Indications for Use (Describe)

The Cochlear Baha® SoundArc is intended for test situations and for patients who cannot or choose not to have an implant for the following indications for use:

· Patients of any age who have a conductive or mixed hearing loss and can still benefit from sound amplification. The pure tone average bone-conduction hearing thressured at 0.5, 1, 2, and 3kHz) should be better than or equal to 45 dB HL for use with the BP100, Baha 4 and Baha 5 sound processors, 55 dB HL for use with the BP110 Power and Baha 5 Power sound processors, and better than or equal to 65 dB HL for use with the Cordelle II and Baha 5 SuperPower Sound Processors.

· 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-conductive thresholds are defined as 10 dB average difference between ears (measured at 0.5, 1,2, and 3 kHz), or less than a 15dB difference at individual frequencies.

· Patients who suffer from unilateral sensorineural deafness in one ear with normal hearing in the other ear (i.e. Singlesided deafness: SSDTM). 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

K171088

Image /page/3/Picture/1 description: The image shows the logo for Cochlear, a company that specializes in hearing solutions. The logo features a stylized, golden-yellow spiral shape resembling a cochlea, which is the part of the inner ear responsible for hearing. Below the spiral is the company name, "Cochlear™", in a simple, sans-serif font.

Sound Processors of the Baha system: K080363, K090720,

K110996, K132278, K142907, K153245, K161123

Hear now. And always

510(k) Summary A. Submitter Information

Secondary System Predicates:

4

K171088

Image /page/4/Picture/1 description: The image shows the Cochlear logo. The logo features a stylized yellow seashell-like symbol to the left of the word "Cochlear" in black font. To the right of the company name is the phrase "Hear now. And always" in a handwritten-style font.

F. Purpose of Submission

The purpose of this Special 510(k) is to introduce a new style of headband, known as Baha SoundArc, which can be used by people of any age and attaches to the existing cleared Baha sound processors. Baha SoundArc provides a more discrete alternative to the currently marketed non-surgical bone conduction options offered by Cochlear Bone Anchored Solutions (CBAS).

G. Device Description

Baha SoundArc is an encapsulated spring wire that wraps around the back of the head and sits behind and above the ears. SoundArc is designed with a symmetrical disc holder that holds the Baha sound processor in place, and is compatible with existing Baha sound processors. The design of SoundArc enables the Baha device to be placed against the skull for operation without the need for a Baha implant to be placed.

H. Intended Use

The Baha system is intended for treatment of patients who have conductive or mixed hearing loss as a result of certain medical conditions such as bilateral atresia and chronic supportive otitis media, and for those who have Single-Sided Deafness (SSD) caused by a congenital condition, surgery, trauma or disease.

The Baha SoundArc, the subject of this Special 510(K), provides a discreet point for connection of existing external Baha sound processors for long-term use on persons of any age, without the need for surgery. The Baha SoundArc may also be used in test situations. The Baha SoundArc does not modify the intended use, functionality, or fundamental operating principles of the Baha svstem.

I. Indications for Use

The Cochlear Baha® SoundArc is intended for test situations and for patients who cannot or choose not to have an implant for the following indications for use:

Patients of any age 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 45 dB HL for use with the BP100, Baha 4 and Baha 5 sound processors, 55 dB HL for use with the BP110 Power and Baha 5 Power sound processors, and better than or equal to 65 dB HL for use with the Cordelle II and Baha 5 SuperPower Sound Processors.
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-conductive 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 15dB difference at individual frequencies.

5

K171088

Image /page/5/Picture/1 description: The image contains the Cochlear logo, which features a stylized yellow spiral shape. Next to the logo, the word "Cochlear" is written in a simple, sans-serif font. Below the logo, the tagline "Hear now. And always" is written in a cursive font.

Patients who suffer from unilateral sensorineural deafness in one ear with normal hearing . in the other ear (i.e. Single-sided deafness: SSDTM). 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.

J. Technological Characteristics

Like the existing Baha Softband and headband, SoundArc transfers vibrations from the sound processor to the mastoid through the skin, without the need for surgery. SoundArc has the same intended use as the currently cleared Baha system, and the same fundamental operating principles and functional characteristics as the existing non-surgical bone conduction headband and Softband for Baha. The existing cleared range of Baha sound processors attach to the SoundArc in the same manner as the predicate device, through snap coupling.

K. Materials

The following new materials in direct and prolonged contact have been evaluated per 10993-1 and shown to be biocompatible and safe for human use:

Silopren LSR 4040 ●
Grilamid L 25 (polyamide) Natural 6112

L. Performance Data

Performance testing was conducted based on a comparison between the proposed SoundArc and the legally marketed Softband and the current Baha sound processors of the predicate Baha system. Substantial equivalence to the predicate system was accomplished through functional and performance tests, design and specification analysis, and biocompatibility evaluation. The results demonstrated the Baha SoundArc is functionally equivalent to the predicate system.

M. Conclusion

Based on the indications for use, technological characteristics, and substantial equivalence comparison to the predicate system, SoundArc has been shown to be safe and effective for its intended use.