The aim of the investigation is to demonstrate that the ATB System provides an improvement in hearing outcomes and quality of life compared to unaided hearing in patients with a conductive or mixed hearing loss or single-sided sensorineural deafness…
ID
Source
Brief title
Condition
- Hearing disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary objective:
1) To compare hearing performance with the Investigational device and the
unaided hearing situation
Primary outcome measure:
1) Thresholds audiometry, free-field [PTA4, Mean of 0.5, 1, 2 and 4 kHz].
Investigational device (at 3 months) vs. Unaided.
2) Adaptive speech in noise [speech-to-noise ratio, 50% speech understanding].
Investigational Device (at 3 months) vs.Unaided (preoperative).
Safety objectives:
Primary safety analysis at 6 months.
1) Implant site evaluations
2) Adverse Events and concomitant medication/treatment
3) Device deficiency
4) Audiogram
Safety outcome measures:
1) Numbness
2) Information will be collected from visit 2 and onwards.
3) Information will be collected from Visit 2 and onwards.
4) Bone conduction thresholds preoperative and postoperative (3,6 and 12
months)
Secondary outcome
Secondary objectives:
1) To compare hearing performance with the Investigational device and the
unaided hearing situation
2) To compare the self-reported assessments of hearing outcome with the
Investigational device and in a preoperative hearing situation
3) To collect surgical information
4) To collect information about the magnet choice and daily use of sound
processor
5) To measure hearing performance preoperatively with a Baha BP110 Power Sound
Processor on a Baha Softband
Secondary outcome measures:
1a) Thresholds audiometry, free-field [PTA4, Mean of 0.5, 1, 2 and 4 kHz].
Investigational device (4w, 6 and 12 months) vs. Unaided.
1b) Thresholds audiometry, free-field [0.25, 0.5, 0.75, 1.0, 1.5, 2.0, 3.0,
4.0, 6.0 and 8.0 kHz]. Investigational device (4w, 3, 6 and 12
months)vs. Unaided.
1c) Adaptive speech in noise [speech-to-noise ratio, 50% speech
understanding]. Investigational Device (4w, 6 and 12 months) vs. Unaided
(preoperative).
1d) Speech in quiet [% correctly perceived words a 50dB, 65dB and 80dB SPL].
Investigational Device (4w, 3, 6, and 12 months) vs. Unaided
(preoperative).
1e) Feedback measurements. Investigational Device (Visit 4 and onwards).
2a) Abbreviated Profile of Hearing Aid Benefit (APHAB). Investigational Device
at 3 and 12 months vs. preoperative hearing situation.
2b)Health Utilities Index (HUI23S1EN.15Q). Investigational device vs.
preoperative hearing situation
2c)Speech, Spatial and Qualities of Hearing Scale (SSQ). Investigational device
vs. Unaided.
3 a) Soft tissue thickness
3b) Soft tissue reduction performed
3c) Type of anaesthesia
3d) Surgery time
3e) Bone polishing/removal at the actuator site
3f) BI300 Implant length
3g) Location of BI300 Implant
3h) Surgical incision type/location
4a) Daily usage time
4b) Comfort
4c) Softpad use
4d) Choice of magnet strength
5a) Thresholds audiometry, free-field [PTA4, Mean of 0.5, 1, 2 and 4 kHz].
5b) Thresholds audiometry, free-field [0.25, 0.5, 0.75, 1.0, 1.5, 2.0, 3.0,
4.0, 6.0 and 8.0 kHz].
5c) Speech in quiet [% correctly perceived words at 50dB, 65dB and 80dB SPL]
5d) Adaptive speech in noise [speech-to-noise ratio, 50% speech
understanding].
5e) BC Direct [0.25, 0.5, 0.75, 1.0, 1.5, 2.0, 3.0, 4.0 and 6.0 kHz].
Tertiary objectives:
1) To measure hearing performance preoperatively with a current hearing aid (if
used by the patient).
Tertiary outcome measures:
1)Adaptive speech in noise [speech-to-noise ratio, 50% speech understanding].
Background summary
The Cochlear Baha bone conduction systems 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 passive Baha Attract System uses a magnetic connection through intact
skin.
Magnetic conduction has the advantage over skin-penetrating systems of
eliminating the daily cleaning, reduction in reported adverse skin reactions of
the implant site and are perceived as more cosmetically appealing by many
subjects. On the other hand, the passive transcutaneous Baha Attract System
offers less efficient bone conduction (especially at high frequencies) due to
attenuation of sound vibrations through the intact skin that separates the
external transducer from the osseointegrated implant, compared to the Baha
Connect System that enables direct bone conduction through the percutaneous
implant.
The ATB System (Osseointegrated Steady State Implant System) is developed to
provide the benefits of a non-skin-penetrating system combined with the
benefits of a skin-penetrating system. Compared to the passive transcutaneous
Baha Attract System, the ATB System will provide a more efficient transmission
of sound, especially in the high frequency range, as the implantable transducer
eliminates the attenuation of sound vibrations through the soft tissue that is
inherent to the passive system. With the ATB System it will also be possible to
position the transducer closer to the ear canal, which may further improve
audiological outcomes.
Study objective
The aim of the investigation is to demonstrate that the ATB System provides an
improvement in hearing outcomes and quality of life compared to unaided hearing
in patients with a conductive or mixed hearing loss or single-sided
sensorineural deafness (SSD). The aim is also to measure and present
preoperative audiological test results with a Baha BP110 Power Sound Processor
on a Baha Softband in relation to the Investigational device. Safety parameters
will be collected.
Study design
Open, prospective, multicentre clinical investigation. The study is
single-sided and randomization and blinding are therefore not applicable.
Intervention
Impantation of the ATB System
Study burden and risks
The ATB system is built up from several components, some of which have already
been CE marked. Nevertheless, there is no guarantee that the ATB system has no
side effects. The patient will be closely monitored during the study and be
instructed to contact the lead investigator if any adverse events are
experienced.
Participation in this study requires undergoing a CT-scan before the operation
and afterwards more follow up visits than what would normally be required. In
addition, the duration of the visit will be a little longer since the patient
will have to perform three times an audiogram which is not done as much in the
standard care. In addition, the study will take extra time for the patient
because they will be requested to complete a questionnaire at 3 visits.
It is expected that the ATB system offers advantages since it is expected that
the transmission of sound will be more efficient, especially at the high
frequencies. In addition, the transducer can be placed closer to the ear canal
which will most likely result in an improved sound transmission in the ear
canal.
Taken into account the risks they are judged acceptable when weighted against
the benefits of the intended performance of the device.
Konstruktionsvagen 14
Molnlycke SE-435 22
SE
Konstruktionsvagen 14
Molnlycke SE-435 22
SE
Listed location countries
Age
Inclusion criteria
* Adult subjects (18 years or older)
* Subject with conductive or mixed hearing loss in the ear to be implanted. Bone conduction thresholds with pure tone average (PTA4; mean of 0.5, 1, 2 and 4 kHz) of <<= 55 dB.
OR
Subject with single-sided sensorineural deafness who is a candidate for Baha surgery. Air conduction thresholds with a pure tone average PTA4 of <<= 20 dB HL (mean of 0.5, 1, 2 and 3 kHz) in the good ear
OR
Subject who is indicated for an AC CROS but*for some reason*cannot or will not use an AC CROS (Air Conduction-Contralateral Routing of Signal).
* Signed informed consent
* Previous experience from amplified sound though properly fitted amplication. (For example but not limited to Hearing aid, CROS device, Bone conductional hearing device on headband/ softband)
Exclusion criteria
* Uncontrolled diabetes as judged by the investigator.
* Condition that could jeopardise osseointegration and/or wound healing (e.g. osteoporosis, psoriasis, long-term systemic use of corticosteroids) or condition that may have an impact on the outcome of the investigation as judged by the investigator.
* Insufficient bone quality and quantity for implantation of a BI300 Implant.
* Subject that has received radiotherapy in the area of implantation, or is planned for such radiotherapy during the study period.
* Use of ototoxic drugs that could be harmful to the hearing, 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.
* The subject is pregnant or lactating
* The subject suffers from psychiatric and/or psychomatic disorder(s)
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| Other | CT-2017-CTN-00631-1 v1(TGA) en NCT03086135 |
| CCMO | NL59620.091.17 |