Mixed Hearing Loss, Unilateral Clinical Trial
Official title:
Evaluation of Audiological Outcomes and Subjective Benefits of Cochlear Baha® 5 SuperPower Sound Processor on the Baha® Attract™ System
| NCT number | NCT02722330 |
| Other study ID # | CBAS5619 |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | April 2016 |
| Est. completion date | December 2016 |
| Verified date | February 2019 |
| Source | Cochlear Bone Anchored Solutions |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 23 |
| Est. completion date | December 2016 |
| Est. primary completion date | December 2016 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
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. |
| Country | Name | City | State |
|---|---|---|---|
| Belgium | Antwerp University Hospital | Antwerp | |
| Denmark | Odense University Hospital | Odense | |
| Spain | Hospital de Sant Pau | Barcelona | |
| United Kingdom | Royal Hallamshire Hospital | Sheffield |
| Lead Sponsor | Collaborator |
|---|---|
| Cochlear Bone Anchored Solutions |
Belgium, Denmark, Spain, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Number of Adverse Events Related to the Treatment | Number of adverse events related to the treatment during the 12 weeks treatment period | 12 weeks | |
| Primary | Audiometry; Free Field Thresholds. Pure Tone Average PTA4,Unaided vs Aided | Change of hearing performance PTA4 [Mean of 0.5, 1, 2 and 4 kHz] from the unaided hearing situation at pre-operation with the Investigational device on the attract system, aided at 12 weeks | 12 weeks | |
| 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. | The APHAB is a 24-item self-assessment questionnaire evaluating the benefit experienced by the subject when using hearing amplification compared to the unaided situation. It comprises of four subscales: Ease of Communication (EC), Reverberation (RV), Background Noise (BN), and Aversiveness (AV). The Global score is the mean of the subscales. All subscales are scored in the same way. The scores show how frequently (%) clients experience performance problems and varies between 0-100, 0 indicates no problems, 100 indicates always problem. Benefit is then calculated by subtracting the aided average from the unaided average. The theoretical benefit score could vary between -100 to + 100. The higher the score the better benefit and positive score indicates an improvement, a negative value an impairment. |
12 weeks | |
| 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. | The SSQ-12 is comprised of 12 items using the response format on a scale from 0 to 10, were 0 equals no ability and 10 equals perfect ability. These are divided into three sub-scales and the questions 1-5 are from the speech sub-scale, 6-8 from the spatial, and 9-12 from the qualities sub-scale. The three sub-scales are the average of the questions within. A 'not applicable' option is given for each item. The change from unaided to aided hearing is then calculated and the theoretical score could vary between -10 to + 10. The higher the score the better benefit and positive score indicates improved hearing, a negative value an impaired hearing. |
12 weeks | |
| Secondary | Audiometry; Free Field Thresholds. Pure Tone Average PTA4 Unaided vs Aided | Change of hearing performance PTA4 [Mean of 0.5, 1, 2 and 4 kHz] from the unaided hearing situation at pre-operation with the Investigational device on the attract system, aided at 4 weeks | 4 weeks | |
| Secondary | Audiometry; Free Field Thresholds Per Frequency, Unaided vs Aided | Change of hearing performance free field tresholds per frequency [0.25, 0.5, 0.75, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0 kHz] from unaided hearing situation at pre-operation with the Investigational device on the attract system, aided at 4 weeks | 4 weeks | |
| Secondary | Audiometry; Free Field Thresholds Per Frequency, Unaided vs Aided | Change of hearing performance free field tresholds per frequency [0.25, 0.5, 0.75, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0 kHz] from unaided hearing situation at pre-operation with the Investigational device on the attract system, aided at 12 weeks | 12 weeks | |
| Secondary | Free Field; - Adaptive Speech Recognition in Noise, Unaided vs Aided | Change of hearing performance free field - adaptive speech recognition in noise from unaided hearing situation at pre-operation with the Investigational device on the attract system, aided at 4 weeks | 4 weeks | |
| Secondary | Free Field; - Adaptive Speech Recognition in Noise, Unaided vs Aided | Change of hearing performance free field - adaptive speech recognition in noise from unaided hearing situation at pre-operation with the Investigational device on the attract system, aided at 12 weeks | 12 weeks | |
| Secondary | Free Field; - Speech Recognition in Quiet, Unaided vs Aided | Change of hearing performance free field - speech recognition in quiet from the unaided hearing situation at pre-operation with the Investigational device on the attract system, aided at 4 weeks | 4 weeks | |
| Secondary | Free Field; - Speech Recognition in Quiet, Unaided vs Aided | Change of hearing performance free field - speech recognition in quiet from the unaided hearing situation at pre-operation with the Investigational device on the attract system, aided at 12 weeks | 12 weeks | |
| Secondary | Audiometry; Free Field Thresholds. Pure Tone Average PTA4, Investigational Device vs Softband | Change of hearing performance PTA4 [Mean of 0.5, 1, 2 and 4 kHz] from the situation with the same sound processor on a Baha soft band at pre-operation with the Investigational device on the attract system at 4 weeks | 4 weeks | |
| Secondary | Audiometry; Free Field Thresholds. Pure Tone Average PTA4 [Mean of 0.5, 1, 2 and 4 kHz], Investigational Device vs Softband | Change of hearing performance PTA4 from the situation with the same sound processor on a Baha soft band at pre-operation with the Investigational device on the attract system at 12 weeks | 12 weeks | |
| Secondary | Audiometry; Free Field Thresholds Per Frequency, Investigational Device vs Softband | Change of hearing performance free field tresholds per frequency [0.25, 0.5, 0.75, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0 kHz] from the situation with same sound processor on a Baha softband with the Investigational device on the attract system at 4 weeks | 4 weeks | |
| Secondary | Audiometry; Free Field Thresholds Per Frequency, Investigational Device vs Softband | Change of hearing performance free field tresholds per frequency [0.25, 0.5, 0.75, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0 kHz] from the same sound processor on a Baha softband with the Investigational device on the attract system at 12 weeks | 12 weeks | |
| Secondary | Free Field - Adaptive Speech Recognition in Noise, Investigational Device vs Softband | Change of hearing performance free field - adaptive speech recognition in noise from the situation with the same sound processor on a Baha softband at pre-operation with the Investigational device on the attract system at 4 weeks | 4 weeks | |
| Secondary | Free Field - Adaptive Speech Recognition in Noise, Investigational Device vs Softband | Change of hearing performance free field - adaptive speech recognition in noise from the situation with the same sound processor on a Baha softband at pre-operation with the Investigational device on the attract system at 12 weeks | 12 weeks | |
| Secondary | Free Field - Speech Recognition in Quiet, Investigational Device vs Softband | Change of hearing performance free field - speech recognition in quiet from the situation with the same sound processor on a Baha Softband with the Investigational device on the attract system at 4 weeks | 4 weeks | |
| Secondary | Free Field - Speech Recognition in Quiet, Investigational Device vs Softband | Change of hearing performance free field - speech recognition in quiet from the situation with the same sound processor on a Baha Softband with the Investigational device on the attract system at 12 weeks | 12 weeks | |
| Secondary | Sound Processor Magnet Selection at 4 Weeks | Information about sound processor magnet selection, type of SP magnet | 4 weeks | |
| Secondary | Sound Processor Magnet Selection at 6 Weeks | Information about sound processor magnet selection, type of SP magnet | 6 weeks | |
| Secondary | Sound Processor Magnet Selection at 12 Weeks | Information about sound processor magnet selection, type of SP magnet | 12 weeks | |
| Secondary | Daily Use of Sound Processor (Average Daily Use During the Last Week) | Average daily use (hours/day) of the sound processor during the last week of the study | 12 weeks |