Clinical trial NCT03086135: Clinical Performance of a New Implant System for Bone Conduction Hearing
Official title: Clinical Performance of a New Implant System for Bone Conduction Hearing
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Deafness; Sensoneural Single Sided
Conductive Hearing Loss
Mixed Hearing Loss
Lead sponsor: Cochlear
Sponsor class: INDUSTRY
First posted: 2017-03-22
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To study the initial experience with implanting and fitting the new Bone conduction system in patients with conductive, mixed or Single sided Sensorineural deafness.


Eligibility criteria: 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 HL.

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 a non-surgical solution. (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.

Primary outcomes:
measure: Hearing Performance: Threshold Audiometry, Pure Tone Average of 4 Frequencies, PTA4, Unaided Versus OSIA System at 3 Months
timeFrame: Baseline before surgery, 3 months after surgery
measure: Adaptive Speech Recognition in Noise, Unaided Versus OSIA System at 3 Months.
timeFrame: Baseline before surgery, 3 months after surgery
Secondary outcomes:
measure: Hearing Performance: Threshold Audiometry, Pure Tone Average, PTA4, Unaided Versus OSIA System at 4 Weeks, 6 and 12 Months
timeFrame: Baseline before surgery, 4 weeks, 6 and 12 months after surgery
measure: Hearing Performance: Threshold Audiometry Individual Frequences, Unaided Versus OSIA System at 4 Weeks, 3, 6 and 12 Months
timeFrame: Baseline before surgery, 4 weeks, 3, 6 and 12 months after surgery.
measure: Speech in Quiet at 50, 65 and 80 dB SPL, Unaided Versus OSIA System at 4 Weeks, 3, 6 and 12 Months
timeFrame: Baseline before surgery, 4 weeks, 3, 6 and 12 months after surgery.
measure: Adaptive Speech Recognition in Noise, Unaided Versus OSIA System at 4 Weeks, 6 and 12 Months
timeFrame: Baseline before surgery, 4 weeks, 6 and 12 months after surgery
measure: Abbreviated Profile of Hearing Aid Benefit (APHAB) at 3 and 12 Months
timeFrame: Baseline before surgery, 3 and 12 months after surgery
measure: Health Utility Index (HUI) at 3 and 12 Months
timeFrame: Baseline before surgery and 3 and 12 months after surgery
measure: Speech, Spatial and Qualities of Hearing Scale (SSQ) at 3 and 12 Months
timeFrame: Baseline before surgery and 3 and 12 months after surgery
measure: Hearing Performance: Threshold Audiometry PTA4, With Reference Device BP110
timeFrame: Baseline before surgery, 4 weeks, 3, 6 and 12 months.
measure: Hearing Performance: Threshold Audiometry Individual Frequences With Reference Device BP110
timeFrame: Baseline before surgery, 4 weeks, 3, 6 and 12 months after surgery.
measure: Speech in Quiet at 50, 65 and 80 dB SPL, With Reference Device BP110
timeFrame: Baseline before surgery, 4 weeks, 3, 6 and 12 months after surgery.
measure: Adaptive Speech Recognition in Noise, With Reference Device BP110
timeFrame: Baseline before surgery, 4 weeks, 3, 6 and 12 months after surgery.
measure: Surgical Information: Time of Surgery
timeFrame: Visit 2, surgery
measure: Soft Tissue Thickness
timeFrame: Visit 2, surgery
measure: Soft Tissue Reduction
timeFrame: Visit 2, surgery
measure: Bone Polishing/Removal at Implant Site
timeFrame: Visit 2, surgery
measure: Type of Anaesthesia
timeFrame: Visit 2, surgery
measure: Location of BI300 Implant
timeFrame: Visit 2, surgery
measure: Incision Type
timeFrame: Visit 2, surgery
measure: Daily Usage Time of Sound Processor
timeFrame: 6 weeks, 3, 6 and 12 months
measure: Comfort
timeFrame: 6 weeks, 3, 6 and 12 months
measure: Magnet Choice
timeFrame: 4, 6 weeks, 3, 6 and 12 months
measure: Softpad Use
timeFrame: 6 weeks, 3, 6 and 12 months
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: East Melbourne
country: Australia
facility: The Royal Victorian Eye and Ear Hospital
state: Victoria
city: Freiburg
country: Germany
facility: University Medical Center Freiburg
state: Baden-Württemberg
city: Nijmegen
country: Netherlands
facility: Radboud University Medical Center
city: Kajetany
country: Poland
facility: World Hearing Center Institute of Physiology and Pathology of Hearing
state: Nadarzyn
Study officials:
affiliation: Radboud Univerity Medical centre
name: Emmanuel Mylanus, Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: The Royal Victorian Eye and Ear Hospita
name: Robert Briggs, Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Universitätsklinikum Freiburg
name: Susan Arndt, Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Center of Hearing and Speech
name: Piotr Skarżyński, Ass.Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Michigan
name: Henry Alexander Arts, Prof.
role: PRINCIPAL_INVESTIGATOR
References: