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The Baha Cordelle II sound processor is intended for use with the Baha auditory osseointegrated implant for the following patients and indications;

• . 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 65 dB HL.
• Bilateral fitting of the Cordelle II is intended for patients who meet the above e 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 or "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.

The Baha system works by combining a sound processor with an abutment and a small titanium implant placed in the skull behind the ear. 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 bone, allowing high-quality amplified and processed sound to be conducted via the skull bone directly to a cochlea with residual functionality.

The Cordelle II is one of three currently marketed sound processors for use with the Baha auditory osseointegrated implant. It is the only analog signal processing and body-worn sound processor, and it offers the highest power output of all the devices.

The provided text describes the Baha® Cordelle II hearing aid, focusing on an expanded indication for use. Here's an analysis of the acceptance criteria and supporting studies based on the provided input:

Acceptance Criteria and Device Performance

The core of this submission is to expand the audiometric fitting range for the Baha Cordelle II. The original acceptance criterion for conductive and mixed hearing loss was a bone-conduction threshold of

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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:

4. 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.

5. 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.

The Branemark 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.

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. 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.

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.

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 provided text is a pre-market notification (510(k)) for the Branemark Bone-Anchored Hearing Aid (BAHA™) Cordelle II System. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed acceptance criteria and a study proving the device meets those criteria in the way one might expect for a novel device or a clinical trial for a new drug.

Here's an analysis based on the information provided:

1. A table of acceptance criteria and the reported device performance

Since this is a 510(k) submission, the "acceptance criteria" are primarily established by the performance of the predicate devices. The claim is substantial equivalence to the predicate products, not necessarily a set of quantitative performance metrics for a novel technology demonstrating clinical efficacy.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The text does not describe a specific "test set" or a clinical study with a defined sample size to prove the device meets acceptance criteria in the traditional sense. The basis for the claims is substantial equivalence to legally marketed predicate devices. The nominal output increase of "13 dB stronger than the Classic 300" is mentioned, which implies some form of acoustic measurement or comparison, but details on the methodology, sample size for this comparison, or data provenance are not provided.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. This is not a study requiring expert-established ground truth for a diagnostic outcome. The submission relies on technical comparisons and the established safety and efficacy of predicate devices.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable, as no described test set requiring adjudication is present.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a hearing aid, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a medical device, not an algorithm. Performance is assessed through its function as a hearing aid in conjunction with a human user.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" in this context is the safety and effectiveness of the predicate devices (Branemark BAHA, K955713 and K984162, and the Craniofacial Prosthetic Attachment System, K945154), which have already been deemed safe and effective for their indicated uses. The Cordelle II system demonstrates substantial equivalence by showing it shares the same intended use, technological characteristics, surgical technique, and similar manufacturing processes, with an improvement in output (stronger amplification) for patients where existing predicate devices might be "too weak."

8. The sample size for the training set

Not applicable. This is not a machine learning or AI device that would have a "training set."

9. How the ground truth for the training set was established

Not applicable.

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