This device is to be used by patients who have a conductive hearing loss and can still benefit from sound amplification. Also indicated are patients with mixed hearing loss with average bone conduction thresholds in the indicated ear better than 45 dB HL. (Patients with bone conduction thresholds between 25 and 45 dB HL will be expected to improve, but may not achieve levels in the normal range. Patients with a bone conduction threshold where each standard measured frequency threshold is less than 25 dB HL can be expected to have restored hearing levels in the normal range.) The patients indicated for this device must also be unable to use conventional air conduction hearing aids or undergo ossicular replacement surgery because of one of the following:

Chronic otitis media (COM), or
Congenital malformation (CM) of the middle/external ear; or
Other acquired malfunctions of the middle or external ear canals which preclude the wearing of a conventional air conduction hearing aid.
Additional indications to be met by perspective BAHA candidates:
Patients (either by themselves or with the aid of others) must be able to maintain the abutment/skin interface of the BAHA. Therefore, careful consideration must be given as to the patient's psychological, physical, emotional and developmental capabilities to maintain hygiene. In the case of children part, but not all, of that responsibility falls on the parents or guardian.
For children and patients with congenital malformations, sufficient bone volume and bone quality must be present for a successful fixture implantation. Alternative treatment such as conventional bone conduction hearing aids, should be considered for patients having a disease state that might jeopardize osseointegration.

Device Description

The Branemark Bone-Anchored Hearing Aid (BAHA) System includes a titanium fixture which is placed in the temporal bone just behind the ear, an abutment, various accessories necessary for the placement and use of the fixture/abutment pillar, and a sound processor which is attached to the abutment. The fixture/abutment pillar is used as an anchor for the sound processor.

AI/ML Overview

The provided text is related to a 510(k) submission for the Branemark Bone-Anchored Hearing Aid (BAHA™) System. This document focuses on regulatory approval and indications for use, rather than a clinical study evaluating specific performance metrics against acceptance criteria. Therefore, most of the requested information regarding acceptance criteria, study details, and performance statistics is not present in the given text.

Based on the provided information, I can offer the following:

1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria or report specific device performance metrics in a way that would fit into such a table. It describes the intended use and expected outcomes (e.g., "expected to improve," "restored hearing levels in the normal range") rather than quantifiable performance thresholds.

2. Sample Size Used for the Test Set and Data Provenance
The document does not describe a "test set" in the context of a clinical study with a specified sample size or data provenance. The information provided is for a 510(k) submission seeking clearance based on substantial equivalence to predicate devices, not a new clinical trial reporting performance data.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not applicable. The document does not describe a clinical study involving experts establishing ground truth for a test set.

4. Adjudication Method for the Test Set
Not applicable. The document does not describe a clinical study with an adjudication method.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size
Not applicable. The document does not describe an MRMC study.

6. If a Standalone (algorithm only without human-in-the-loop performance) was done
Not applicable. The device described is a medical implant and sound processor, not an artificial intelligence algorithm.

7. The Type of Ground Truth Used
Not applicable in the context of an AI/algorithm performance study. The "ground truth" for the device's efficacy is implied by its ability to amplify sound and improve hearing based on its mechanism of action and prior clinical experience with similar devices, as described in the predicate products.

8. The Sample Size for the Training Set
Not applicable. The document does not describe a training set for an algorithm.

9. How the Ground Truth for the Training Set was Established
Not applicable.

In summary, the provided 510(k) document is a regulatory submission focused on the safety and effectiveness of a medical device (a bone-anchored hearing aid) and its indications for use, including an expansion to pediatric patients. It establishes substantial equivalence to previously cleared predicate devices but does not detail a new clinical study with specific performance acceptance criteria or detailed study methodologies as would be expected for demonstrating algorithm performance.

Summary

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510(k) 984162

SUMMARY OF SAFETY AND EFFECTIVENESS

A. Name and Address

The Summary of Safety and Effectiveness is being submitted by Nobel Biocare USA, Inc., administrative office at 3944 N. Hampton Drive, Powell, Ohio, 43065. The telephone number is: 1-888-825-8484.

B. Name of Device

The device is generally known as a bone-anchored, bone-conduction hearing aid with the trade name "Branemark Bone-Anchored Hearing Aid (BAHA™) System. This submission is to allow the Branemark Bone-Anchored Hearing Aid to be used in patients from 5 years old and older.

C. The Predicate Product

The predicate product used in this Premarket Notification is the Branemark System® Bone-Anchored Craniofacial Prosthetic Attachment System (K945154), the Branemark Bone-Anchored Hearing Aid (K955713), the Audiant™ Bone-Conduction Hearing Aid (K861971, K872168 and K841432), and other bone-conduction hearing aids.

D. Description of Device

Page 1 of 3

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SUMMARY OF SAFETY AND EFFECTIVENESS (continued)

E. Indications for Use

1. Chronic otitis media (COM), or
1. Congenital malformation (CM) of the middle/external ear; or
1. Other acquired malfunctions of the middle or external ear canals which preclude the wearing of a conventional air conduction hearing aid.

Additional indications to be met by perspective BAHA candidates:

1. Patients (either by themselves or with the aid of others) must be able to maintain the abutment/skin interface of the BAHA. Therefore, careful consideration must be given as to the patient's psychological, physical, emotional and developmental capabilities to maintain hygiene. In the case of children part, but not all, of that responsibility falls on the parents or guardian.
1. For children and patients with congenital malformations, sufficient bone volume and bone quality must be present for a successful fixture implantation. Alternative treatment such as conventional bone conduction hearing aids, should be considered for patients having a disease state that might jeopardize osseointegration.

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510(k) 984162

SUMMARY OF SAFETY AND EFFECTIVENESS (continued)

E. Indications for Use (continued)

Contraindications:

Speech discrimination scores of the indicted car less the 60% at elevated sound 1. pressure levels (SPL) during standardized tests.
1. Patients who are developmentally delayed or who suffer from drug abuse. (This includes children who have behavior problems or who have parents who are not able to keep the implanted area clean.
1. Age less than 5 years.
1. Patients who already have a BAHA (i.e. no bilateral implants). The BI-CROS attachment to the BAHA should be used for this purpose.

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Image /page/3/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a circular design with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three lines representing its wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 28 1999

Nobel Biocare c/o Ms. Betsy A. Brown B.A. Brown & Assoc. Regulatory Specialists 8944 Tamaroa Terrace Skokie, Illinois 60076

Re: K984162

Trade Name: Branemark Bone Anchored Hearing Aid (BAHA™) System Regulatory Class: II Product Code: 77 MAH Dated: April 12, 1999 Received: April 15, 1999

Dear Ms. Brown:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations .

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Page 2 - Ms. Betsy A. Brown

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

A. Ralph Rosenthal

A. Ralph Rosenthal, M.D. Director Division of Ophthalmic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): K984162- S1

Device Name: Branemark Bone-Anchored Hearing Aid (BAHA™) System for Pediatric Use

Indications For Use:

1. Chronic otitis media (COM); or
1. Congenital malformation (CM) of the middle/external ear; or
1. Other acquired malfunctions of the middle or external ear canals which preclude the wearing of a conventional air conduction hearing aid.

Additional indications to be met by perspective BAHA candidates:

1. Patients (either by themselves or with the aid of others) must be able to maintain the abutment/skin interface of the BAHA. Therefore, careful consideration must be given as to the patient's psychological, physical, emotional and developmental capabilities to maintain hygiene. In the case of children part, but not all, of that responsibility falls on the parents or guardian.
1. For children and patients with congenital malformations. sufficient bone volume and bone quality must be present for a successful fixture implantation. Alternative treatment such as conventional bone conduction hearing aids. should be considered for patients having a disease state that might jeopardize osseointegration.

(Please do not write below line-continue on another page if needed) Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use(Per 21 CFR 801.109)	OR	Over-the-Counter Use_
------------------------------------------	----	-----------------------

(Division Sign-Off)
Division of Ophthalmic Devices
510(k) Number	K984162
	EDD

(Optional Format I-2-96)

Signature

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page 2

510(k) Number (if known): K984162-S1

Device Name: Branemark Bone Anchored Hearing Aid (BAHA™) System for Pediatric Use

Contraindications:

1. Speech discrimination scores of the indicated ear less the 60% at elevated sound pressure levels (SPL) during standardized tests.
1. Patients who are developmentally delayed or who suffer from drug abuse. (This includes children who have behavior problems or who have parents who are not able to keep the implanted area clean.)
1. Age less than 5 years.
1. Patients who already have a BAHA (i.e. no bilateral implants.) The BI-CROS attachment to the BAHA should be used for this purpose.

(Please do not write below line-continue on another page if needed) Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use	✓ (Per 21 CFR 801.109)
------------------	------------------------

Over-the-Counter Use	____
----------------------	------

(Division Sign-Off)
Division of Ophthalmic Devices

510(k) Number	K984162
---------------	---------

C2J
(Optional Format I-2-96)

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.