Hearing Loss Clinical Trial
Official 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
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
Status | Completed |
Enrollment | 27 |
Est. completion date | February 2014 |
Est. primary completion date | February 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Australia | The HEARing CRC & HearWorks, University of Melbourne | Melbourne | Victoria |
Chile | Clinica Las Condes | Santiago | |
Hong Kong | The Chinese University of Hong Kong | Hong Kong | |
Israel | Bnai Zion MedicalCenter | Haifa |
Lead Sponsor | Collaborator |
---|---|
Cochlear Bone Anchored Solutions |
Australia, Chile, Hong Kong, Israel,
Briggs R, Van Hasselt A, Luntz M, Goycoolea M, Wigren S, Weber P, Smeds H, Flynn M, Cowan R. Clinical performance of a new magnetic bone conduction hearing implant system: results from a prospective, multicenter, clinical investigation. Otol Neurotol. 201 — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Hearing performance | To compare the hearing performance with Baha Attract/sound processor with the hearing performance with the system currently used by the subject To compare the hearing performance with Baha Attract/sound processor with the hearing performance with softband/sound processor The following audiological tests will be performed:free field thresholds, speech recognition in noise and speech recognition in quiet |
Baseline and week 4, 6, 12, 30 | No |
Other | Time to perform surgery | Visit 2 (surgery) | No | |
Other | Choice of Sound Processor | To compare the sound processors BP100 and BP110 attached to a soft band(subject preference) | Baseline | No |
Other | Feedback measurement | Perform feedback measurements and investigate if this changes over time. 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. | Baseline and week 4 and 12 | No |
Other | Magnetic force | To investigate if the magnetic force required for sound processor magnet retention will change over time | Week 4, 6, 12 and 30 | No |
Other | Safety | Skin evaluation Pain Numbness Removal of inner magnet Device deficiency Adverse events • Adverse Events |
Week 0 to 30 | Yes |
Other | Tissue reduction performed during surgery | Visit 2 (surgery) | No | |
Other | Implant stability | Implant Stability Quotient - ISQ | Visit 2 (surgery) | No |
Primary | Hearing performance | To compare the hearing performance with Baha Attract/sound processor (aided) with the unaided hearing performance before surgery. The following audiological tests will be performed:free field thresholds, speech recognition in noise and speech recognition in quiet | Baseline | No |
Primary | Hearing Performance | To compare the hearing performance with Baha Attract/sound processor (aided) with the unaided hearing performance before surgery | Week 4 | No |
Primary | Hearing performance | To compare the hearing performance with Baha Attract/sound processor (aided) with the unaided hearing performance before surgery | Week 6 | No |
Primary | Hearing performance | To compare the hearing performance with Baha Attract/sound processor (aided) with the unaided hearing performance before surgery | Week 12 | No |
Primary | Hearing performance | To compare the hearing performance with Baha Attract/sound processor (aided) with the unaided hearing performance before surgery | Week 30 | No |
Secondary | Hearing Aid Outcome | To compare the Self-Report Assessment of Hearing Aid Outcome before and after use of Baha Attract/sound processor | Baseline and week 12, 30 | No |
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