Clinical trial NCT04041700: Clinical Performance, Safety and Patient Reported Outcomes of an Active Osseointegrated Steady-State Implant System
Official title: A Prospective, Multicentre, Open Clinical Investigation Evaluating Clinical Performance, Safety and Patient Reported Outcomes With an Active Osseointegrated Steady-State Implant System (OSI) in Adult Subjects With Conductive Hearing Loss, Mixed Hearing Loss or Single-sided Sensorineural Deafness
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hearing Loss
Keywords: Hearing Loss, Conductive
Hearing Loss, Mixed
Deafness, sensorineural single-sided
Lead sponsor: Cochlear
Sponsor class: INDUSTRY
Collaborators: name: Statistiska Konsultgruppen
First posted: 2019-08-01
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of this clinical investigation is to collect data on objective and subjective hearing performance, quality of life and safety in adult subjects with conductive hearing loss, mixed hearing loss or single-sided sensorineural deafness.


Eligibility criteria: Inclusion Criteria:

* Subject with conductive hearing loss 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 sensorineural hearing loss.

OR Subject with single-sided sensorineural deafness who is a candidate for Baha surgery. Air conduction thresholds with a pure tone average PTA4 (mean of 0.5, 1, 2 and 3 kHz) of ≤ 20 dB sensorineural hearing loss in the good ear OR subject who is indicated for an (Air Conduction-Contralateral Routing of Signal (AC CROS) but-for some reason-cannot or will not use an AC CROS.

* Adult subjects (18 years or older).
* Previous experience from amplified sound through properly fitted amplification (for example but not limited to Hearing aid, Contralateral Routing of Signal (CROS) device, Bone conduction hearing device on softband).
* Candidate is a fluent speaker in the language used to assess speech perception performance.
* Willing and able to provide written informed consent

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 to support successful implant placement.
* Previous surgery and/or implantation with any bone conduction/active device on the side to be implanted, which may jeopardise the implantation and use of the Osia 2 system, as judged by the investigator.
* 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, or unwilling to comply with the requirements of the clinical investigation as determined by the investigator.
* Condition with a likely negative progression and/or with expected relapses jeopardising general wellbeing and health-related quality of life as judged by the investigator.
* Subject that has received radiotherapy in the area of implantation or is planned for such radiotherapy during the study period.
* Investigator site personnel directly affiliated with this study and/or their immediate families; immediate family is defined as a spouse, parent, child, or sibling.
* Cochlear employees or employees of Contract Research Organisations or contractors engaged by Cochlear for the purposes of this investigation
* Currently participating, or participated within the last 30 days, in another interventional clinical investigation involving an investigational drug or device.

Primary outcomes:
measure: Change in Hearing Performance With the Osia 2 System at 3 Months Post-surgery Compared to Preoperative Unaided Condition Assessed Via Audiometric Thresholds
timeFrame: Baseline before surgery, 3 months after surgery
measure: Change in Hearing Performance With the Osia 2 System at 3 Months Post-surgery Compared to Preoperative Unaided Situation Assessed Via Adaptive Speech Recognition in Noise
timeFrame: Baseline before surgery, 3 months after surgery
Secondary outcomes:
measure: Change in Hearing Performance With the Osia 2 System at 4 Weeks and 6 Months Post Surgery Compared to Preoperative Unaided Situation Assessed Via Audiometric Thresholds
timeFrame: Baseline before surgery, 4 weeks and 6 months after surgery
measure: Change in Hearing Performance With the Osia 2 System at 4 Weeks and 6 Months Post Surgery Compared to Preoperative Unaided Situation Assessed Via Adaptive Speech Recognition in Noise
timeFrame: Baseline before surgery, 4 weeks and 6 months after surgery
measure: Change in Hearing Performance With the Osia 2 System at 4 Weeks, 3 Months and 6 Months Post Surgery Compared to Preoperative Unaided Situation Assessed Via Audiometric Thresholds
timeFrame: Baseline before surgery, 4 weeks, 3 months and 6 months after surgery
measure: Change in Hearing Performance With the Osia 2 System at 4 Weeks, 3 Months and 6 Months Post Surgery Compared to Preoperative Unaided Situation Assessed Via Speech Recognition in Quiet
timeFrame: Baseline before surgery, 4 weeks, 3 months and 6 months after surgery
measure: Change in Self-reported Hearing Outcome With the Osia 2 System at 3 Months and 6 Months Post Surgery Compared to the Preoperative Unaided Situation Via Abbreviated Profile of Hearing Aid Benefit (APHAB) Questionnaire
timeFrame: Baseline before surgery, 3 months and 6 months after surgery
measure: Change in Self-reported Hearing Outcome With the Osia 2 System at 3 Months and 6 Months Post Surgery Compared to the Preoperative Unaided Situation Via the Speech, Spatial and Qualities of Hearing Scale (SSQ) Questionnaire
timeFrame: Baseline before surgery, 3 months and 6 months after surgery
measure: Change in Health-related Quality of Life With the Osia 2 System at 3 Months and 6 Months Post Surgery Compared to the Preoperative Unaided Situation Via the Health Utilities Index Mark III (HUI) Questionnaire
timeFrame: Baseline before surgery, 3 months and 6 months after surgery
measure: Surgical Information: Soft Tissue Thickness
timeFrame: Baseline before surgery or at surgery
measure: Surgical Information: Surgery Time
timeFrame: At surgery
measure: Surgical Information: Bone Polishing/Removal at the Actuator Site
timeFrame: At surgery
measure: Surgical Information: BI300 Implant Length
timeFrame: At surgery
measure: Surgical Information: Location of BI300 Implant
timeFrame: At surgery
measure: Surgical Information: Type of Anesthesia
timeFrame: At surgery
measure: Surgical Information: Soft Tissue Reduction
timeFrame: At surgery
measure: Surgical Information: Surgical Incision Type
timeFrame: At surgery
measure: Surgical Information: Location of the Surgical Incision in Relation to the Actuator
timeFrame: At surgery
measure: Surgical Information: Estimated Length of the Surgical Incision
timeFrame: At surgery
measure: Surgical Information: Placement of the Coil
timeFrame: At surgery
measure: Usability Information: Magnet Choice
timeFrame: At 4 weeks, 6 weeks, 3 months and 6 months after surgery
measure: Usability Information: Sound Processor Retention
timeFrame: At 4 weeks, 6 weeks, 3 months and 6 months after surgery
measure: Usability Information: Sound Processor Wearing Comfort
timeFrame: At 4 weeks, 6 weeks, 3 months and 6 months after surgery
measure: Usability Information: Use of SoftWear Pad
timeFrame: At 6 weeks, 3 months and 6 months after surgery
measure: Usability Information: Daily Use of Sound Processor
timeFrame: At 6 weeks, 3 months and 6 months after surgery
measure: Usability Information: Daily Streaming Time of Sound Processor
timeFrame: At 6 weeks, 3 months and 6 months after surgery
measure: Usability Information: Battery Lifetime of Sound Processor
timeFrame: At 6 weeks, 3 months and 6 months after surgery
measure: Difference in Hearing Performance Between the Osia 2 System and a Baha 5 Power Sound Processor on a Baha Softband (Preoperative) at 4 Weeks, 3 Months and 6 Months Post Surgery Assessed Via Audiometric Thresholds
timeFrame: Baseline before surgery, 4 weeks, 3 months and 6 months after surgery
measure: Difference in Hearing Performance Between the Osia 2 System and a Baha 5 Power Sound Processor on a Baha Softband (Preoperative) at 4 Weeks, 3 Months and 6 Months Post Surgery Assessed Via Audiometric Thresholds
timeFrame: Baseline before surgery, 4 weeks, 3 months and 6 months after surgery
measure: Difference in Hearing Performance Between the Osia 2 System and a Baha 5 Power Sound Processor on a Baha Softband (Preoperative) at 4 Weeks, 3 Months and 6 Months Post Surgery Assessed Via Adaptive Speech Recognition in Noise
timeFrame: Baseline before surgery, 4 weeks, 3 months and 6 months after surgery
measure: Difference in Hearing Performance Between the Osia 2 System and a Baha 5 Power Sound Processor on a Baha Softband (Preoperative) at 4 Weeks, 3 Months and 6 Months Post Surgery Assessed Via Speech Recognition in Quiet
timeFrame: Baseline before surgery, 4 weeks, 3 months and 6 months after surgery
measure: Hearing Performance Using a Baha Softband (Preoperative) at Baseline and the Osia 2 System at 4 Weeks, 3 Months and 6 Months Post Surgery Assessed Via Bone Conduction (BC) Direct
timeFrame: Baseline before surgery, 4 weeks, 3 months and 6 months after surgery
Other outcomes:
Locations:
city: Gladesville
country: Australia
facility: Sydney Cochlear Implant Centre
city: Melbourne
country: Australia
facility: The Royal Victorian Eye and Ear Hospital
city: Hong Kong
country: Hong Kong
facility: Department of Otorhinolaryngology, Head and Neck Surgery Faculty of Medicine. The Chinese University of Hong Kong
Study officials:
affiliation: Cochlear
name: Karin Ganlöv
role: STUDY_DIRECTOR
References:
citation: Briggs R, Birman CS, Baulderstone N, Lewis AT, Ng IHY, Ostblom A, Rousset A, Tari S, Tong MCF, Cowan R. Clinical Performance, Safety, and Patient-Reported Outcomes of an Active Osseointegrated Steady-State Implant System. Otol Neurotol. 2022 Aug 1;43(7):827-834. doi: 10.1097/MAO.0000000000003590.