N/A
Completed N=27
Clinical Performance of a Transcutaneous Bone Conduction Hearing Solution (Baha® Attract System)
Deafness · Hearing Loss · Hearing Loss, Conductive
Source: ClinicalTrials.gov NCT01822119 ↗
Enrolled (actual)
27
Serious AEs
7.4%
Results posted
Feb 2017
Primary outcomePrimary: Hearing Performance, PTA4 at 12 Weeks — -18.4 dB — p=<0.0001
Summary
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
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Hearing Performance, PTA4 at 12 Weeks |
-18.4 | <0.0001 sig |
| PRIMARY Hearing Performance, PTA4 at 36 Weeks |
-18.4 | <0.0001 sig |
| SECONDARY Hearing Performance, Individual Frequencies |
-20.2; -25.2; -18.3; -18.7; -9.8; -5.0 | <0.0001 sig |
| SECONDARY Hearing Performance, PTA4, Sound Processor on Softband Versus Baha Attract at 36 Weeks |
0.926 | 0.39 |
| SECONDARY Hearing Performance, Individual Frequencies, Sound Processor on Softband Versus Baha Attract at 36 Weeks |
-0.741; -1.67; 1.67; -0.37; 4.44; 6.92 | 0.79 |
| SECONDARY Hearing Performance, Speech in Quiet, Unaided Versus Baha Attract at 36 Weeks |
50; 46.4; 24.2 | <0.0001 sig |
| SECONDARY Hearing Performance, Speech in Quiet, Aided With the Sound Processor on a Softband Versus Baha Attract at 36 Weeks |
2.83; 0.98; 1.71 | 0.55 |
| SECONDARY Hearing Performance, Speech in Noise, Unaided Versus Baha Attract at 36 Weeks |
-15.0 | <0.0001 sig |
| SECONDARY Hearing Performance, Speech in Noise, Aided With the Sound Processor on a Softband Versus Baha Attract at 36 Weeks |
-3.79 | 0.0092 sig |
| SECONDARY Abbreviated Profile of Hearing Aid Benefit (APHAB) |
-4.04; 4.23; 5.10; 8.92; 6.76 | 0.59 |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01822119). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.