BRANEMARK BONE-ANCHORED HEARING AID (BAHA) CORDELLE II

K992872 · Entific Medical Systems, Inc. · LXB · Nov 24, 1999 · Ear, Nose, Throat

Device Facts

• Record ID: K992872
• Device Name: BRANEMARK BONE-ANCHORED HEARING AID (BAHA) CORDELLE II
• Applicant: Entific Medical Systems, Inc.
• Product Code: LXB · Ear, Nose, Throat
• Decision Date: Nov 24, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.3302
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Indications for Use

The Branemark Bone-Anchored Hearing Aid (BAHA™) Cordelle II System is intended to be used as a bone-anchored, bone-conduction hearing aid. The device is indicated for use in patients who have 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 45dB HL. The nominal output from the BAHA Cordelle II is on average 13 dB stronger than the Classic 300 (measured at 0.5, 1, 2, 3 kHz). The Cordelle II is recommended for patients having the same indications for the Classic 300 but where slightly stronger amplification is needed than what is delivered by the Classic 300 model. (Patients with bone conduction thresholds better than 45dB 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: 1. Chronic otitis media (COM); or 2. Congenital malformation (CM) of the middle/external ear; or 3. 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 parent or guardian. 2. For children and patients with congenital malformation, 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 Story

Bone-anchored hearing aid system; consists of titanium fixture implanted in temporal bone, percutaneous abutment, and external sound processor. Sound processor connects to body-worn unit via cord. Body-worn unit features two potentiometers (threshold knee, loudness boost) and three-position tone control switch (Normal, High-frequency emphasis, Low-frequency emphasis). Device receives audio via microphone, telecoil, or electrical input (e.g., FM/IR system). Audiologist adjusts gain settings using screwdriver. Patient or caregiver maintains abutment/skin interface hygiene. System provides bone-conducted sound amplification for patients with conductive/mixed hearing loss; bypasses middle/external ear pathologies. Benefits include restored hearing levels for qualified candidates.

Clinical Evidence

No clinical data provided. Substantial equivalence based on identical technological characteristics and surgical technique to predicate devices.

Technological Characteristics

Titanium fixture, abutment, and gold screw. Percutaneous connection. Body-worn unit with analog potentiometers for threshold knee and loudness boost. Three-position tone control switch. Electrical input for FM/IR systems. Titanium materials. Sterilization process identical to predicates.

Indications for Use

Indicated for patients age 5+ with conductive or mixed hearing loss (bone conduction threshold better than 45dB HL in indicated ear) unable to use conventional air conduction aids or undergo ossicular replacement due to chronic otitis media, congenital malformation, or acquired middle/external ear canal malfunctions. Contraindicated for patients with speech discrimination <60% at elevated SPL, developmental delays, drug abuse, age <5, or existing BAHA (no bilateral implants).

Regulatory Classification

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.

Predicate Devices

• Branemark Bone-Anchored Hearing Aid (BAHA™) (K955713)
• Branemark Bone-Anchored Hearing Aid (BAHA™) (K984162)
• Branemark System® Bone Anchored Craniofacial Prosthetic Attachment System (K945154)

Submission Summary (Full Text)

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Pre-market Notification

goy 2 4 1998

# K992872

#### Summary of Safety and Effectiveness

# A. Name and Address

The Summary of Safety and Effectiveness is being submitted by Entific Medical Systems Inc., 3944 N. Hampton Drive, Powell, Ohio 43065 (formerly part of Nobel Biocare USA, 22895 East Park Drive, Yorba Linda California 92887). The contact person for this submission will be Betsy A. Brown, the regulatory specialist for Entific Medical Systems Inc. Ms. Brown can be reached at the following:

> B.A. Brown & Asociates 8944 Tamaroa Terrace Skokie, Illinois 60067 Tel# [phone] Fax# [phone]

#### B. Name of Device

This device is generally known as a bone-anchored, bone-conduction hearing aid with a body worn unit, and has the trade name "Branemark Bone-Anchored Hearing Aid (BAHA™) Cordelle II System. This submission is to allowthe BAHA Cordelle II System to be used in patients 5 years old or older.

## C. The Predicate Product

The predicate products used in this Premarket Notification are the Branemark Bone-Anchored Hearing Aid (BAHA™), K955713 and K984162, the Branemark System® Bone Anchored Craniofacial Prosthetic Attachment System, K945154 and other bone conduction hearing aids.

# D. Description of the Device

The Braneniark Bone-Anchored Hearing Aid (BAHA™) Cordelle II System includes a titanium fixture which is placed in the temporal bone just behind the ear, an abutment, vanous accessories necessary for the placement and use of the fixture/abutment pillar, a sound processor which is attached to the abutment and a body worn unit which has two potentiometers that control threshold knee and loundness boost and a tone control switch.

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# E. Intended Use of the Device

The Branemark Bone-Anchored Hearing Aid (BAHA™) Cordelle II System is intended to be used as a bone-anchored, bone-conduction hearing aid. The device is indicated for use in patients who have conductive hearing loss and can still benefit from menoded for ass in passeria dicated are patients with mixed hearing loss with average bone sound anipulisation. I is the indicated ear better than 45dB HL. The nominal output from the BAHA Cordelle II is on average 13 dB stronger than the Classic 300 (measured at 0.5, 1,2,3 kHz). The Cordelle II is recommended for patients having the same indications for r, 2,5 he m. The Classic 300 is "too weak". (Patients with bone conduction thresholds better than 45dB HL will be expected to improve, but may not achieve levels in the normal range. Patients with a bone conduction threshold where each standard the normal range, I annovation 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:

- 1. Chronic otitis media (COM); or
- 2. Congenital malformation (CM) of the middle/external ear; or
- 3. 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 psycholoigical, physical, emotional and developmental capabilities to maintain hygiene. In the case of children part, but not all, of that responsibility falls on the parent or guardian.
- 2. For children and patients with congenital malformation, 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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#### Pre-market Notification

## Contraindications:

- 1. Speech discrimination scores of the indicated ear less than 60% at elevated sound pressure levels (SPL) during standardized tests.
- 2. 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.)
- 3. Age less than 5 Years.
- 4. Patients who already have a BAHA™ (i.e. no bilateral implants.) The BI-CROS attachment to the BAHA should be used for this purpose.

#### F. Comparison of Technological Characteristics

The technological characteristics between the attachment system, the sound processor and the respective predicate products are substantially identical and no additional questions regarding safety and effectiveness exist.

#### Substantial Equivalence

The Branemark Bone-Anchored Hearing Aid (BAHA™) Cordelle IEjs a sound processor system which consists of two units; a transducer and a body worn unit. The body worn unit has two potentiometers which control threshold knee and loudness boost and a tone control switch.

## Transducer

The transducer is an at-the-ear level sound processor which uses a direct connection to the skull bone without intervening skin and soft tissue. The transducer is attached to a snap coupling titanium abutment, which is fastened to a titanium flange fixture using a gold screw. The transducer is connected to a body worn unit via a cord with electrical output and input connectors.

#### Body Worn Unit

As noted previously the body worn unit has two potentiometers which control the threshold knee and loudness boost. The unit is also equipped with an electrical input to receive signals from a "Walkman" FM/IR system. When the electrical contact is connected it overrides the telecoil signal.

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# Body Worn Unit (continued)

The body worn unit has a tone switch which controls the frequency response. The switch can be set in three different positions. N= Normal, which gives the widest frequency response. H= High frequency emphasis (reduction of low frequency sounds). L= Low frequency emphasis (reduction of high frequency sounds). The tone switch is effective for all inputs (microphone, telecoil, electrical).

The two trim controls marked LB and TK can be adjusted with a small screwdriver by the patient's audiologist. The LB adjusts the gain for loud sounds and the TK adjusts the gain for soft sounds.

The body worn unit is equipped with a clip so you can attach the unit to the patient's clothing (i.e. shirt/blouse pocket ... ).

## Abutment Snap

There is an abutment snap which is mounted to the transducer. It is designed to snap into the abutment and hold the transducer securely in place.

## Abutment Insert

The function of the abutment insert is to act as a guide for the abutment snap. It makes it easier to connect the transducer to the abutment. It also protects the inside of the abutment from dirt.

#### Abutment and Abutment Screw

The abutment is a replaceable percutancous connection between the fixture and the external sound processor which is partially or totally submerged into soft tissue. The abutment is made of titanium and is fastened to the fixture via an internal an abutment screw.

#### Abutment Cover

When the transducer is not in place you can attach the abutment cover on the abutment to make it look more aesthetically pleasing. One can attach the cover by pressing it into place on the abutment.

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#### Pre-market Notification

# Fixture

The fixture is a threaded titanium screw which is implanted into the temporal bone and intended to provide permanent bone anchorage as a means to attach the sound processor.

- az

### Cover Screw and Healing Cap

The cover screw and healing cap are temporary components utilized only during the healing periods post surgical placement of the titanium fixture. The cover screw is used during the first healing period and is arrached to the fixture and covered with the soft tissue during the healing of the bone and soft tissue. The covers the upper part of the internal threads of the fixture. Thus, the cover screw will preclude bone and soft tissue from growing into the site where the abutment will be placed. The healing cap is used during the second healing period and covers the abutment surface. These components are used only during the healing stages of the surgery and remain in place for three to four months and one to two weeks respectively.

The Branemark Bone-Anchored Hearing Aid BAHA®™Cordelle II System is substantially equivalent to the Branemark Bone-Anchored Hearing Aid BAHA™, K955713, K984162 and to the Branemark System® Bone-Anchored Craniofacial Prosthetic Attachment System (BA-CPAS), K9445154 for the following:

- 1. The BAHA Cordelle II System has the same intended use as the predicate products
- 2. The BAHA Cordelle II System has the same identical technological characteristics as the predicate products
- 3. The BAHA Cordelle II System has the same identical surgical technique as the predicate products
- 4. The BAHA Cordelle II System has similar manufacturing processes; and same packaging and sterilization process as the predicate products

Therefore, based on the facts presented above, we believe the BAHA™ Cordelle II System is substantially equivalent to the predicate products and respectfully request the concurrence of the Agency.

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Image /page/5/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo consists of a stylized image of an eagle with three curved lines representing its wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter of the circle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Nov 2 4 1999

Ms. Betsy A. Brown Regulatory Specialist for Entific Medical Systems B. A. Brown & Associates 8944 Tamaroa Terrace Skokie, IL 60076

Re: K992872 Trade Name: Branemark Bone-Anchored Hearing Aid (BAHA) Cordelle II Regulatory Class: II Product Code: 77LXB Dated: July 28, 1999 Received: August 26, 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 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). 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 mishranding 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 OS 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 devices as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your devices to legally marketed predicate devices results in a classification for your devices and thus, permits your devices to proceed to the market.

If you desire specific advice for your devices on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your devices, please contact the Office of Compliance at [phone]. 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 tollfree number [phone] or at [phone].

Sincerely yours,

Alvez L 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): # 992872

Device Name; Branematk Bone Anchored Hearing Aid (BAHA™) System Cordelle II System

Indications For Use:

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 45dB HL. The nominal output from the BAHA Cordelle II is on average 13 dB stronger than the Classic 300 model (measured at 0.5,1,2,3 kHz). The Cordelle is recommended for patients having the same indications for the Classic 300 but where slightly stronger amplification is needed than what is delivered by the Classic 300 model. (Patients with bone conduction

> thresholds better than 45dB HL will be expected to improve, but may not activeve 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:

1. Chronic otitis media (COM); or

2. Congenital malformation (CM) of the middle/external ear; or

- 3. 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™Cordelle II 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.
- 2. 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 V (Per 21 CFR 801.109)

OR

Over-the-Counter Use

Karen L. Baker
(Division Sign-Off)

Division of Ophthalmic Devices

510(k) Number K993872

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.

# Contraindications:

- 1. Speech discrimination scores of the indicated ear less the 60% at elevated sound pressure levels (SPL) during standardized tests.
- 2. Patients who are developmentally delayed or who suffer from drug abusc. (This includes children who have behavior problems or who have parents who are not able to keep the implanted area clean.)
- 3. Age less than 5 years.

- 4. Patients who already have a BAHA (i.e. no bilateral implants.) The BI-CROS attachment to the BAHA should be used for this purpose.
.