Patients of any age for use with the Baha Softband or headband. 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 3 kHz) should be better than or equal to 45 dB HL.
Bilateral fitting is intended for patients who meet the 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 Deafness; 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 subject of this Special 510(k): Device Modification is a modification to the Cochlear BP100 sound processor, which was cleared under 510(k) K090720 for unilateral use with conductive and mixed hearing losses (as a result of congenital malformations such as atresia, or certain medical conditions such as chronic suppurative otitis media), and for cases of single-sided sensorineural deafness (SSD, caused by a congenital condition, surgery, trauma or disease). The Baha system has been marketed for more than 30 years throughout the world, and there are now more than 100,000 users of a Baha system globally.

Baha sound processors can be used with either the external Baha headband or Softband in persons of any age, or for children aged 5 or older with the Baha auditory osseointegrated implants. The external Baha headband or Softband system works via conventional transcutaneous bone conduction amplification. The Baha implant system works by combining the external sound processor with an abutment and a small titanium implant placed in the skull behind the ear in a simple surgical procedure. The system is based on the process of "osseointegration" through which living tissue integrates with titanium in the implant. Thus, the titanium implant becomes one with the surrounding bone, allowing high-quality amplified and processed sound from the Baha sound processor to be conducted via the skull bone directly to a cochlea with residual functionality. For either form of transmission, the processed sound either bypasses a conductive block in those patients with conductive or mixed hearing loss, or transfers sound through the skull to the opposite-ear normal cochlea for patients with SSD.

The modified sound processor, the Baha 4 is an upgrade to the currently marketed Baha BP100 sound processor, which it will replace on the U.S. market. The Baha 4 sound processor is mechanically identical to the BP100, but replaces the ASIC inside the processor with an off-theshelf electronic assembly used in currently marketed air conduction devices. The modified device utilizes the same fundamental scientific principles, and has the same intended use and indications for use as the current legally marketed device it will replace. In addition, the Baha 4 is compatible with certain 2.4GHz devices currently marketed for use with air conduction hearing aids.

AI/ML Overview

The provided 510(k) summary for the Cochlear Baha 4 Sound Processor does not contain acceptance criteria or a study proving that the device meets specific performance criteria.

This document is a Special 510(k), indicating that the device is a modification of a previously cleared device (Cochlear BP100 sound processor, K090720). Special 510(k)s often focus on demonstrating that the modified device is substantially equivalent to the predicate device despite technological improvements, rather than presenting new clinical performance studies against specific acceptance criteria.

The summary states that the Baha 4 sound processor is "mechanically identical to the BP100, but replaces the ASIC inside the processor with an off-the-shelf electronic assembly used in currently marketed air conduction devices." It also claims that the modified device "utilizes the same fundamental scientific principles, and has the same intended use and indications for use as the current legally marketed device it will replace."

Therefore, I cannot populate the table or answer the specific questions regarding acceptance criteria and performance studies because the information is not present in the provided text.

Here's what the document does provide and why it doesn't fit the requested format:

Device Description and Technological Characteristics: It details the modifications made to the Baha BP100, primarily replacing the internal ASIC with a new electronic assembly from air conduction devices. These modifications allow for new features like 2.4GHz wireless connectivity, additional program slots, wind noise detection/reduction, 17-channel sound analysis, and automatic scene analysis.
Intended Use and Indications for Use: These remain the same as the predicate device.
Substantial Equivalence Claim: The crux of this 510(k) is the assertion that, despite the technological improvements, the Baha 4 sound processor "still has substantially equivalent function and technology, and the same intended use as the predicate Baha BP100 sound processor." This means the manufacturer is arguing that the new features do not raise new questions of safety or effectiveness and that existing performance data for the predicate device, or general understanding of the technology, applies.

In summary, the provided text does not include:

A table of acceptance criteria and reported device performance.
Sample sizes, data provenance, number of experts, or adjudication methods for a test set.
Details of a multi-reader multi-case (MRMC) comparative effectiveness study.
Details of a standalone algorithm performance study.
Information on the type of ground truth used for a performance study.
Sample size for a training set or how its ground truth was established.

This is typical for a Special 510(k) where the focus is on demonstrating substantial equivalence to a predicate device rather than conducting new efficacy or performance trials against novel acceptance criteria.

Summary

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K132278

510(k) Summary

In accordance with the Safe Medical Devices Act (SMDA) of 1990 and Title of the Code of Federal Regulations Part 807 (21 CFR §807), and in particular §807.92, the following summary of safety and effectiveness information is provided.

Submitted by:

Cochlear Americas 13059 East Peakview Ave. Centennial, CO 80111

SEP 26 2013

On behalf of:

Cochlear Bone Anchored Solutions AB Konstruktionsvägen 14 SE-435 33 Mölnlycke Sweden

Contact Persons:

Sean Bundy Sr. Manager, Regulatory Affairs and Compliance Phone: 303-524-7139 Facsimile: 303-524-6825 Email: SBundy@cochlear.com

Date Submission Prepared:

July 2013

Device Name:

Trade or Proprietary Name: Common or Usual Name: Classification Status: Product Codes: Panel:

Cochlear Baha® 4 Sound Processor Bone Anchored Sound Processor Class II, 21 CFR §874.3300 LXB Ear Nose and Throat Devices Panel

Cochlear Baha 4 Sound Processor – Special 510(k)

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Device Description:

Intended Use:

The new Baha 4 will be used as an external sound processor option (in the Cochlear Baha family of sound processors) to conduct sound energy directly to the cochlea via a Baha auditory osseointegrated implant, or via transcutaneous transmission with a Baha headband or Softband. This is the same intended use, and for the same patient population, as the current legally marketed, unmodified Baha BP100 device (the predicate device that it will replace).

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Technological Characteristics:

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

The primary modifications proposed are technological improvements so that the Baha 4 can take advantage of several features that are inherent to the new electronic assembly. These include:

2.4GHz wireless audio and data connection capability .
One additional program slot (for a total of 4) .
Wind noise detection and reduction .
17-channel sound analysis .
. Automatic scene analysis

The Baha Fitting Software (also cleared under K090720) has been updated to incorporate support for communication with the new electronic assembly, as well as allowing the fitting audiologist to enable or disable features of the new electronic assembly.

Conclusions:

Despite technological improvements and the upgrade to new sound processing features, the Baha 4 sound processor still has substantially equivalent function and technology, and the same intended use as the predicate Baha BP100 sound processor cleared for marketing under K 090720. The indication for use statement is also the same as that for the current legally marketed Baha BP100 sound processor that it will replace.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wings. The eagle is positioned to the right of a circular text element that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

ood and Drug Administration 0903 New Hampshire Avenue Document Control Center - WO66-C760 Silver Spring, MD 20993-0002

September 26,2013

Cochlear Americas % Mr. Sean Bundy Director, Regulatory Strategy, Cochlear Americas 13059 E Peakview Ave Centennial, CO 80111

Re: K132278

Trade/Device Name: Baha 4 Sound Processor Regulation Number: 21 CFR 874.3300 Regulation Name: Hearing Aid Regulatory Class: Class II Product Code: LXB Dated: August 27, 2013 Received: August 27, 2013

Dear Mr. Bundy:

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 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 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 803); good manufacturing practice requirements as set

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Page 2 - Mr. Sean Bundy

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 Small Manufacturers, International and Consumer Assistance at its toll-

free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note

the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers. International and Consumer Assistance 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

Enclosure

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Indications For Use

510(k) Number (if known): K 132278

Device Name: Cochlear Baha 4 Sound Processor

Indications for Use Statement:

The Cochlear Baha® 4 sound processor has the following indications for use:

. Patients of any age for use with the Baha Softband or headband. 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 3 kHz) should be better than or equal to 45 dB HL.
Bilateral fitting is intended for patients who meet the 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 Deafness; 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.

Prescription Use X

Over-The-Counter Use --------AND/OR

(21 CFR 801 Subpart C)

(Part 21 CFR 801 Subpart D)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Image /page/5/Picture/16 description: The image shows the name "Sageev George -S" in bold, followed by the date and time "2013.09.26 11:53:19" and the timezone offset "-04'00"" below it. The text is clear and legible, with a simple sans-serif font. The background is plain, which makes the text stand out.

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.