N/A
Completed N=23
Evaluation of Cochlear Baha 5 SuperPower Sound Processor on the Baha Attract System
Single Sided Sensorineural Deafness · Mixed Hearing Loss, Unilateral
Source: ClinicalTrials.gov NCT02722330 ↗
Enrolled (actual)
23
Serious AEs
0.0%
Results posted
Jun 2019
Primary outcomePrimary: Audiometry; Free Field Thresholds. Pure Tone Average PTA4,Unaided vs Aided — -27.7 dB HL — p=<0.0001
Summary
The aim of this clinical investigation is to evaluate objective and subjective hearing performance with the Cochlear Baha 5 SuperPower Sound Processor on the Baha Attract System, compared to the unaided hearing performance. Comparison of audiological test results with the same sound processor on a Baha Softband will also be performed. Short term safety parameters will be collected.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Audiometry; Free Field Thresholds. Pure Tone Average PTA4,Unaided vs Aided |
-27.7 | <0.0001 sig |
| SECONDARY Change of the Self-reported Assessments of Hearing Outcome Using Abbreviated Profile of Hearing Aid Benefit (APHAB) From the Unaided Hearing Situation at Pre-operation With the Investigational Device on the Attract System, at 12 Weeks. |
44.8; 31.5; 37.7; -16.6; 38.0 | <0.0001 sig |
| SECONDARY Change of the Self-reported Assessments of Hearing Outcome Using Speech, Spatial and Qualities of Hearing Scale (SSQ-12) From the Unaided Hearing Situation at Pre-operation With the Investigational Device on the Attract System, Aided at 12 Weeks. |
3.59; 2.37; 3.51 | <0.0001 sig |
| SECONDARY Audiometry; Free Field Thresholds. Pure Tone Average PTA4 Unaided vs Aided |
-27.0 | <0.0001 sig |
| SECONDARY Audiometry; Free Field Thresholds Per Frequency, Unaided vs Aided |
-24.3; -27.6; -33.0; -32.2; -35.9; -32.4 | <0.0001 sig |
| SECONDARY Free Field; - Adaptive Speech Recognition in Noise, Unaided vs Aided |
-8.41 | 0.0024 sig |
| SECONDARY Free Field; - Speech Recognition in Quiet, Unaided vs Aided |
35.7; 49.0; 39.2 | <0.0001 sig |
| SECONDARY Audiometry; Free Field Thresholds. Pure Tone Average PTA4, Investigational Device vs Softband |
2.55 | 0.036 sig |
| SECONDARY Audiometry; Free Field Thresholds. Pure Tone Average PTA4 [Mean of 0.5, 1, 2 and 4 kHz], Investigational Device vs Softband |
1.9 | 0.065 |
| SECONDARY Audiometry; Free Field Thresholds Per Frequency, Investigational Device vs Softband |
-2.39; -2.61; 1.09; 2.39; 1.52; 2.17 | 0.12 |
| SECONDARY Free Field - Adaptive Speech Recognition in Noise, Investigational Device vs Softband |
1.42 | 0.11 |
| SECONDARY Free Field - Speech Recognition in Quiet, Investigational Device vs Softband |
-9.00; -1.17; 2.82 | 0.096 |
| SECONDARY Sound Processor Magnet Selection at 4 Weeks |
0; 2; 3; 11; 5; 2 | — |
| SECONDARY Sound Processor Magnet Selection at 6 Weeks |
0; 5; 8; 7; 2; 1 | — |
| SECONDARY Sound Processor Magnet Selection at 12 Weeks |
2; 3; 8; 10; 0; 0 | — |
| SECONDARY Daily Use of Sound Processor (Average Daily Use During the Last Week) |
9.39 | — |
Eligibility Criteria
Inclusion Criteria
- Adult subjects ≥ 18 years of age
- Mixed hearing loss in the ear to be implanted. Bone conduction thresholds with pure tone average (PTA4, Mean of 0.5, 1, 2 and 4kHz) of 30-55 dBHL or
- Single-sided sensorineural deafness: Bone conduction thresholds with a pure tone average [PTA4, Mean of 0.5, 1, 2 and 4 kHz] of lower or 30 dBHL in the best ear. Subjects who have, for some reason, experienced no or limited benefit from other sound processors when tested on a Baha Softband.
- Subjects suitable for surgery according to the recommended surgical procedure for Cochlear Baha 5 SuperPower with no previous implant on the side to be investigated.
- Signed inform consent.
Exclusion Criteria
- Subject scheduled for simultaneous bilateral implant surgery. The investigation is limited to subjects with unilateral use of the Investigational device (however, bilateral hearing loss is not an exclusion criterion).
- Suitable implant position for the BI300 Implant (4 mm or 3 mm) not found during surgery due to insufficient bone quality and/or bone thickness
- Less than 3 mm soft tissue thickness at the planned implant site. (Intra-operative exclusion criteria judged by the surgeon at Visit 1 or Visit 2 according to local practice).
- Subjects that have received radiation therapy at the same side of the skull where the Investigational device will be positioned.
- Uncontrolled diabetes as judged by the investigator.
- Condition that could jeopardise osseointegration and/or wound healing (e.g. osteoporosis, psoriasis and long-term systemic use of corticosteroids) or condition that may have an impact on the outcome of the investigation as judged by the investigator.
- Unable to follow investigational procedures, e.g. to complete quality of life scales.
- Participation in another clinical investigation with pharmaceutical and/or device.
Data sourced from ClinicalTrials.gov (NCT02722330). 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.