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Completed

NCT Number: NCT01822119

Clinical Performance of a Transcutaneous Bone Conduction Hearing Solution (Baha® Attract System)

The rationale behind this clinical performance investigation is to collect data regarding the usability of the Baha Attract System in patients with hearing impairment that are candidates for Baha surgery:

* To describe the expected hearing performance with the Baha Attract in comparison to unaided hearing thresholds or a pre-test situation using a sound processor together with a softband * Which sound processor to select, i.e. BP100 vs BP110 * Improve the fitting process for the sound processor * Selection of sound processor magnet at time of fitting and over time

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Key information

Conditions

Deafness Ear Diseases Hearing Disorders Hearing Loss Hearing Loss, Conductive Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The HEARing CRC & HearWorks, University of Melbourne, Melbourne, Victoria, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Conductive hearing loss in the implanted ear. Bone conduction thresholds with a pure tone average of 500, 1000, 2000 and 3000 Hz <30 decibel (dB) hearing level (HL)
  • Single-sided Sensorineural Deafness (SSD). Bone conduction thresholds with a pure tone average of 500, 1000, 2000 and 3000 Hz <30 dB hearing level (HL) in the best ear
  • Signed informed consent

Exclusion criteria

  • Uncontrolled diabetes as judged by the investigator
  • Condition that could jeopardize osseointegration and/or wound healing, e.g. osteoporosis, psoriasis and use of corticosteroids
  • Unable to follow investigational procedures, e.g. to complete quality of life scales
  • Less than 4mm of soft tissue pre-operatively
  • Participation in another investigation with pharmaceuticals and/or device
  • Condition that may have an impact on the outcome of the investigation as judged by the investigator
  • Subjects that have received radiation therapy at the same side of the skull where the Baha Attract will be positioned
  • Suitable implant position for the Baha BI300 implant system (4 mm and 3 mm) not found during surgery due to insufficient bone quality and/or bone thickness

Treatment and study plan

Baha Attract System

Device

Primary outcomes

  1. Hearing Performance, PTA4 at 12 Weeks

    Time frame: Baseline before surgery and 12 weeks after surgery

    The change in pure-tone thresholds in free field measured by the difference in pure tone average PTA4 (Mean of thresholds at 500, 1000, 2000 and 4000 Hz) from the pre-operative unaided condition to the aided situation with the Baha Attract System at week 12.

  2. Hearing Performance, PTA4 at 36 Weeks

    Time frame: Baseline before surgery and 36 weeks after surgery

    The change in pure-tone thresholds in free field measured by the difference in pure tone average PTA4 (Mean of thresholds at 500, 1000, 2000 and 4000 Hz) from the pre-operative unaided condition to the aided situation with the Baha Attract System at week 36.

Secondary outcomes

  1. Hearing Performance, Individual Frequencies

    Time frame: Baseline before surgery and 36 weeks after surgery

    The change in pure-tone thresholds in free field measured by the difference at individual frequencies from the pre-operative unaided condition to the aided situation with the Baha Attract System at week 36.

  2. Hearing Performance, PTA4, Sound Processor on Softband Versus Baha Attract at 36 Weeks

    Time frame: Baseline before surgery and 36 weeks after surgery

    The change in pure-tone thresholds in free field measured by the difference in pure tone average PTA4 (Mean of thresholds at 500, 1000, 2000 and 4000 Hz) from the pre-operative aided situation with the Sound Processor on a softband to the aided situation with Baha Attract System at week 36.

  3. Hearing Performance, Individual Frequencies, Sound Processor on Softband Versus Baha Attract at 36 Weeks

    Time frame: Baseline before surgery and 36 weeks after surgery

    The change in pure-tone thresholds in free field measured by the difference in hearing levels of individual frequencies from the pre-operative aided situation with the Sound Processor on a softband to the aided situation with Baha Attract System at week 36.

  4. Hearing Performance, Speech in Quiet, Unaided Versus Baha Attract at 36 Weeks

    Time frame: Baseline before surgery and 36 weeks after surgery

    The change in hearing performance, speech in quiet from the pre-operative unaided condition to the aided situation with the Baha Attract System at week 36.

  5. Hearing Performance, Speech in Quiet, Aided With the Sound Processor on a Softband Versus Baha Attract at 36 Weeks

    Time frame: Baseline before surgery and 36 weeks after surgery

    The change in hearing performance, speech in quiet from the pre-operative aided situation with the Sond Processor on a softband to the aided situation with the Baha Attract System at week 36.

  6. Hearing Performance, Speech in Noise, Unaided Versus Baha Attract at 36 Weeks

    Time frame: Baseline before surgery and 36 weeks after surgery

    The change in hearing performance, speech in noise from the pre-operative unaided condition to the aided situation with the Baha Attract System at week 36.

  7. Hearing Performance, Speech in Noise, Aided With the Sound Processor on a Softband Versus Baha Attract at 36 Weeks

    Time frame: Baseline before surgery and 36 weeks after surgery

    The change in hearing performance, speech in noise from the pre-operative aided situation with the Sond Processor on a softband to the aided situation with the Baha Attract System at week 36.

  8. Abbreviated Profile of Hearing Aid Benefit (APHAB)

    Time frame: Baseline before surgery and 36 weeks after surgery

    Change of APHAB scoring from the unaided pre-operative situation to the aided situation with Baha Attract at 36 weeks. APHAB questionnaire is a 24-item self-assessment inventory that evaluates the benefit experienced by the patient when using hearing amplification compared to the unaided situation. APHAB produces a Global score and scores for four subscales: ease of communication (EC), reverberation (RV), background noise (BN), and aversiveness (AV). The absolute APHAB scale is between 0 and 100%, where 0% indicates no problem and 100% indicates always problem. The change from unaided to aided hearing is presented. A positive value indicates an improvement, a negative value an impairment. This scale applies to all reported scores.

Other outcomes

  1. Time to Perform Surgery

    Time frame: Visit 2 (surgery)

  2. Tissue Reduction Performed During Surgery

    Time frame: Visit 2 (surgery)

    Surgical thinning of the soft tissue flap was advocated when the soft tissue thickness exceeded 6 mm.

  3. Implant Stability

    Time frame: Visit 2 (surgery)

    Implant Stability Quotient - ISQ, a scale from 1 to 100, where 100 represent the highest stability.

  4. Choice of Sound Processor

    Time frame: Baseline

    Type of sound processors BP100 and BP110 attached to a soft band (subject preference)

  5. Feedback Measurement, BP100

    Time frame: Baseline before surgery and 12 weeks after surgery

    Difference between softband measurement at visit 1 and measurement with the Baha Attract system at visit 6. Feedback is a measure of how much sound from the actuator (vibrator) returns to the microphones thus creating a loop of sound which sounds like high pitch noise. Measuring this is a part of the performance of the system, i.e how much gain can the sound processor produce before feedback occurs. Unit of measure is dB re output. A negative value of the change means less feedback.

  6. Feedback Measurement, BP110

    Time frame: Baseline before surgery and 12 weeks after surgery

    Difference between softband measurement at visit 1 and measurement with the Baha Attract system at visit 6. Feedback is a measure of how much sound from the actuator (vibrator) returns to the microphones thus creating a loop of sound which sounds like high pitch noise. Measuring this is a part of the performance of the system, i.e how much gain can the sound processor produce before feedback occurs. Unit of measure is dB re output. A negative value of the change means less feedback.

  7. Magnetic Force

    Time frame: Week 4, 6, 12 and 36

    To investigate if the magnetic force required for sound processor magnet retention will change over time

  8. Safety; Skin Evaluation

    Time frame: 36 weeks

    Evaluation of the skin using the Patient and Observer Scar Assessment Scale (POSASa scale from 1 (normal skin) to 10 (worst scar imaginable).

  9. Safety; Pain

    Time frame: 36 weeks

    Evaluation of neuropathic pain or pain in the scar the last week by asking the patients to rate their experience on a scale from 1 (no, not at all) to 10 (yes, very much).

  10. Safety; Numbness

    Time frame: 36 weeks

    Evaluation of numbness by asking the patients if they had experienced any numbness within 2 cm from the centre of the implant magnet or within and beyond 2 cm from the centre of the implant magnet.

Sponsors and collaborators

Lead sponsor

Cochlear Bone Anchored Solutions

Industry

Registry information

Official study title

Clinical Performance of a Transcutaneous Bone Conduction Hearing Solution (Baha® Attract System). A Multicentre, Open, Prospective Clinical Investigation. 3 Months Investigation With a 6 Months Follow-up

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Apr 2, 2013
Registry last updated
Feb 6, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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