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The BAHA Divino is intended 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 threshold should be better than or equal to 45 dB HL (measured at 0.5, 1, 2 and 3 kHz)

• Bilateral fitting of the Divino is intended for patients who suffer from moderate to severe bilateral symmetric conductive and/or mixed hearing losses. Symmetric bone conductive thresholds are defined as less than 10 dB in average (measured at 0.5, 1, 2 and 4 kHz) or less than 15 dB at individual frequencies

• The single sided deafness (SSD) indication for the Divino hearing aid is intended for patients who suffer from unilateral sensorineural deafness on one ear while the other ear has normal hearing. Normal hearing is defined as PTA AC threshold equal to or better than 20dB measured at 0.5, 1, 2 and 3 kHz

BAHA for SSD is also indicated for patients who are indicated for an AC CROS but who for some reason cannot or will not use an AC CROS.

The BAHA Divino is a bone conduction-type hearing aid. Unlike conventional hearing aids, which depend on acoustic coupling through the air, the Divino is based on a bone conduction technology.

The Divino hearing aid is connected to a fixture pillar, which has been surgically placed in the bone behind the deaf ear. Sound is transmitted through the bones of the skull to the hearing ear with the normal functioning cochlea.

Here's a breakdown of the acceptance criteria and study information for the BAHA Divino hearing aid, based on the provided document:

Acceptance Criteria and Device Performance

Study Details

The provided document describes a 510(k) Premarket Notification for the BAHA Divino. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than conducting new clinical trials to establish independent safety and effectiveness thresholds. Therefore, much of the information typically found in a clinical study report (like detailed sample sizes, expert qualifications for ground truth, MRMC studies, or standalone performance metrics) is not present in this document.

Here's what can be extracted and what is missing:

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

   • Not explicitly stated. The document mentions "software validation and functional testing" but does not provide details on specific test sets (patient data, etc.) or their provenance. This is typical for a 510(k) submission where the primary evidence is a comparison to a predicate device and technical verification/validation.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not applicable/Not explicitly stated. The submission relies on demonstrating technical and functional equivalence, not on a clinical "ground truth" validation against expert consensus on a patient cohort in the way a diagnostic AI might.

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

   • Not applicable/Not explicitly stated. No clinical adjudication method is described.

4. 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:

   • No. This is not an MRMC study. The device is a hearing aid, not a diagnostic AI system for image interpretation.

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

   • Not applicable. While the device has "digital sound processing," the document describes "software validation and functional testing" to verify functional equivalence. It doesn't present "standalone performance" in the context of an algorithm making a decision, but rather as a device performing its intended function.

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

   • Functional equivalence to predicate device and internal technical specifications. The "ground truth" for this submission is that the BAHA Divino performs its intended function (sound amplification via bone conduction) in a manner substantially equivalent to existing BAHA devices and compliant with its own design specifications validated through software and functional testing. It is not based on a clinical "ground truth" related to disease detection or specific outcomes in a trial.

7. The sample size for the training set:

   • Not applicable/Not explicitly stated. As this is a medical device (hearing aid) and not an AI/ML model being "trained" on a dataset for prediction, there isn't a "training set" in the conventional sense of machine learning. The digital sound processing would be designed and validated based on engineering principles and performance specifications.

8. How the ground truth for the training set was established:

   • Not applicable. See point 7.

Summary of the Study:

The "study" described in this 510(k) submission is primarily a comparison of the BAHA Divino to legally marketed predicate devices (previous BAHA models and air conduction hearing aids with digital sound processing) to demonstrate substantial equivalence.

• Focus: Substantial equivalence based on technological characteristics, intended use, and materials.
• Testing: Included "software validation and functional testing" to verify that the Divino is functionally equivalent to the predicate BAHA devices. The details of these tests (e.g., number of units tested, specific metrics) are not provided in this summary.
• Conclusion: Entific Medical Systems concluded that the BAHA Divino is substantially equivalent and presents no new concerns about safety and effectiveness. The FDA concurred with this determination.

Crucially, no new clinical trials or studies generating novel clinical evidence of safety or effectiveness are described, nor are they typically required for a 510(k) submission that demonstrates substantial equivalence to predicate devices for which safety and effectiveness have already been established.

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The use of BAHA hearing aid for SSD is intended to improve speech recognition.

The single sided deafness (SSD) indication for BAHA hearing aid is intended for patients who suffer from unilateral sensorineural deafness on one ear while the other ear has normal hearing. Normal hearing is defined as PTA AC threshold equal to or better than 20dB measured at 0.5, 1, 2 and 3 kHz.

BAHA for SSD is also indicated for patients who are indicated for an AC CROS but who for some reason cannot or will not use an AC CROS.

The BAHA is a bone conduction-type hearing aid. Unlike conventional hearing aids, which depend on acoustic coupling through the air, the BAHA is based on a bone conduction technology.

The BAHA hearing aid is connected to a fixture pillar, which has been surgically placed in the bone behind the deaf ear. Sound is transmitted through the bones of the skull to the hearing ear with the normal functioning cochlea.

Here's a breakdown of the acceptance criteria and study information for the Branemark Bone Anchored Hearing Aid (BAHA) for Single Sided Deafness (SSD), based on the provided text:

Acceptance Criteria and Reported Device Performance

The provided text focuses on the substantial equivalence determination for the BAHA for SSD. While it doesn't explicitly list "acceptance criteria" in a table format with numerical targets, the underlying assumption for substantial equivalence is that the device performs at least as well as or similarly to the predicate devices for its intended use.

The primary performance metrics assessed relate to improvement in hearing and speech recognition.

Study Details

1. Sample Size used for the test set and the data provenance:

   • Sample Size: Not specified in the provided text.
   • Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). The text only states "A clinical study was conducted."

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • This information is not provided in the document. The study evaluated audiometric performance and subjective responses directly from patients, not through expert review of data that would require a ground truth panel.

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

   • Not applicable/Not specified. The study primarily relies on direct audiometric measurements and patient-reported outcomes (questionnaires), which do not typically involve adjudication in the same way as image interpretation studies.

4. 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:

   • No MRMC comparative effectiveness study was done, as this device is a hearing aid, not an AI-assisted diagnostic tool for human readers.

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

   • Not applicable. The BAHA is a medical device that physically aids hearing; it is not an algorithm, and its performance is inherently human-in-the-loop (the patient wearing it).

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

   • The "ground truth" for the effectiveness of the BAHA in this context would be:
     • Audiometric evaluation of speech perception in noise: Objective measures of how well patients could understand speech in challenging listening environments.
     • Subjective questionnaire (APHAB): Patient-reported outcomes on the benefit and satisfaction with the device in real-world situations.

7. The sample size for the training set:

   • Not applicable. This is a medical device, not an AI/machine learning model that requires a "training set."

8. How the ground truth for the training set was established:

   • Not applicable. See point 7.

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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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