Clinical trial NCT02722330: Evaluation of Cochlear Baha 5 SuperPower Sound Processor on the Baha Attract System
Official title: Evaluation of Audiological Outcomes and Subjective Benefits of Cochlear Baha® 5 SuperPower Sound Processor on the Baha® Attract™ System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Single Sided Sensorineural Deafness
Mixed Hearing Loss, Unilateral
Lead sponsor: Cochlear Bone Anchored Solutions
Sponsor class: INDUSTRY
First posted: 2016-03-30
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief 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.

Detailed description: The Cochlear Baha bone conduction hearing implant offers two alternative ways to transmit vibrations from the external sound processor to the osseointegrated implant: The Baha Connect System uses a skin-penetrating abutment and allows direct bone conduction. The Baha Attract System uses a magnetic connection through intact skin. Magnetic bone conduction hearing implants have the advantage over skin-penetrating systems of eliminating the daily cleaning of the site and are perceived as a more cosmetically appealing by some subjects. With modern sound processor technology, it is possible to obtain good sound transmission despite the soft tissue attenuation that is inherent to magnetic bone conduction hearing implants. Clinical investigations have shown that the Baha Attract System, when used in combination with existing head-worn sound processors within the Premium (e.g. BP100, Baha 4 Sound Processors) and Power (BP110 Sound processor) segments, provides good hearing outcomes in subjects with conductive and mild mixed hearing loss.

The Cochlear Baha 5 SuperPower Sound Processor is the first head-worn sound processor within the Super Power segment and has a fitting range of 65 dBHL. It is CE marked and is intended for subjects with mixed hearing loss or single-sided sensorineural deafness (SSD). It can be used with the Baha Connect and Baha Attract Systems and with a Baha Softband. When used in combination with the Baha Attract System, it will be able to compensate for a larger sensorineural component than the current Premium and Power sound processors and, hence, will allow more subjects to benefit from the Baha Attract System. The combination Baha Attract System with Baha 5 SuperPower Sound Processor is the most powerful non-skin penetrating bone conduction hearing implant solution available today.

The Baha 5 SuperPower Sound Processor includes discreet design, advanced signal processing and improved connectivity to external sound sources. The new sound processor supports Cochlear's 2.4 GHz wireless protocol and is programmable with a new version of the Baha 5 Fitting Software.

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.

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.

Primary outcomes:
measure: Audiometry; Free Field Thresholds. Pure Tone Average PTA4,Unaided vs Aided
timeFrame: 12 weeks
Secondary outcomes:
measure: 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.
timeFrame: 12 weeks
measure: 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.
timeFrame: 12 weeks
measure: Audiometry; Free Field Thresholds. Pure Tone Average PTA4 Unaided vs Aided
timeFrame: 4 weeks
measure: Audiometry; Free Field Thresholds Per Frequency, Unaided vs Aided
timeFrame: 4 weeks
measure: Audiometry; Free Field Thresholds Per Frequency, Unaided vs Aided
timeFrame: 12 weeks
measure: Free Field; - Adaptive Speech Recognition in Noise, Unaided vs Aided
timeFrame: 4 weeks
measure: Free Field; - Adaptive Speech Recognition in Noise, Unaided vs Aided
timeFrame: 12 weeks
measure: Free Field; - Speech Recognition in Quiet, Unaided vs Aided
timeFrame: 4 weeks
measure: Free Field; - Speech Recognition in Quiet, Unaided vs Aided
timeFrame: 12 weeks
measure: Audiometry; Free Field Thresholds. Pure Tone Average PTA4, Investigational Device vs Softband
timeFrame: 4 weeks
measure: Audiometry; Free Field Thresholds. Pure Tone Average PTA4 [Mean of 0.5, 1, 2 and 4 kHz], Investigational Device vs Softband
timeFrame: 12 weeks
measure: Audiometry; Free Field Thresholds Per Frequency, Investigational Device vs Softband
timeFrame: 4 weeks
measure: Audiometry; Free Field Thresholds Per Frequency, Investigational Device vs Softband
timeFrame: 12 weeks
measure: Free Field - Adaptive Speech Recognition in Noise, Investigational Device vs Softband
timeFrame: 4 weeks
measure: Free Field - Adaptive Speech Recognition in Noise, Investigational Device vs Softband
timeFrame: 12 weeks
measure: Free Field - Speech Recognition in Quiet, Investigational Device vs Softband
timeFrame: 4 weeks
measure: Free Field - Speech Recognition in Quiet, Investigational Device vs Softband
timeFrame: 12 weeks
measure: Sound Processor Magnet Selection at 4 Weeks
timeFrame: 4 weeks
measure: Sound Processor Magnet Selection at 6 Weeks
timeFrame: 6 weeks
measure: Sound Processor Magnet Selection at 12 Weeks
timeFrame: 12 weeks
measure: Daily Use of Sound Processor (Average Daily Use During the Last Week)
timeFrame: 12 weeks
Other outcomes:
measure: Number of Adverse Events Related to the Treatment
timeFrame: 12 weeks
Locations:
city: Antwerp
country: Belgium
facility: Antwerp University Hospital
city: Odense
country: Denmark
facility: Odense University Hospital
city: Barcelona
country: Spain
facility: Hospital de Sant Pau
city: Sheffield
country: United Kingdom
facility: Royal Hallamshire Hospital
Study officials:
affiliation: Royal Hallamshire Hospital
name: Jaydip Ray, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital de Sant Pau
name: César Orús, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital, Antwerp
name: Paul Van de Heyning, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Odense University Hospital
name: Jesper Schmidt, Dr
role: PRINCIPAL_INVESTIGATOR
References: