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

Cochlear3 sites in 2 countries29 target enrollmentAugust 16, 2019

ConditionsHearing Loss

Overview

Phase: N/A
Intervention: Not specified
Conditions: Hearing Loss
Sponsor: Cochlear
Enrollment: 29
Locations: 3
Primary Endpoint: 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
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

August 16, 2019

End Date

September 24, 2020

Last Updated

4 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Cochlear

Responsible Party

Sponsor

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

Outcomes

Primary Outcomes

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

Time Frame: Baseline before surgery, 3 months after surgery

Speech-to-noise ratio, 50% speech understanding

Change in Hearing Performance With the Osia 2 System at 3 Months Post-surgery Compared to Preoperative Unaided Condition Assessed Via Audiometric Thresholds

Time Frame: Baseline before surgery, 3 months after surgery

Free field (Pure Tone Average 4, mean of 0.5, 1,2 and 4 kHz)

Secondary Outcomes

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(Baseline before surgery, 4 weeks and 6 months after surgery)
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(Baseline before surgery, 4 weeks and 6 months after surgery)
Surgical Information: Placement of the Coil(At surgery)
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(Baseline before surgery, 4 weeks, 3 months and 6 months after surgery)
Surgical Information: Soft Tissue Thickness(Baseline before surgery or at surgery)
Usability Information: Magnet Choice(At 4 weeks, 6 weeks, 3 months and 6 months after surgery)
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(Baseline before surgery, 4 weeks, 3 months and 6 months after surgery)
Surgical Information: Type of Anesthesia(At surgery)
Surgical Information: Soft Tissue Reduction(At surgery)
Surgical Information: Surgical Incision Type(At surgery)
Usability Information: Daily Streaming Time of Sound Processor(At 6 weeks, 3 months and 6 months after surgery)
Usability Information: Battery Lifetime of Sound Processor(At 6 weeks, 3 months and 6 months after surgery)
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(Baseline before surgery, 3 months and 6 months after surgery)
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(Baseline before surgery, 3 months and 6 months after surgery)
Surgical Information: Bone Polishing/Removal at the Actuator Site(At surgery)
Surgical Information: Location of BI300 Implant(At surgery)
Surgical Information: Location of the Surgical Incision in Relation to the Actuator(At surgery)
Surgical Information: Estimated Length of the Surgical Incision(At surgery)
Usability Information: Sound Processor Retention(At 4 weeks, 6 weeks, 3 months and 6 months after surgery)
Usability Information: Use of SoftWear Pad(At 6 weeks, 3 months and 6 months after surgery)
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(Baseline before surgery, 4 weeks, 3 months and 6 months after surgery)
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(Baseline before surgery, 3 months and 6 months after surgery)
Surgical Information: Surgery Time(At surgery)
Surgical Information: BI300 Implant Length(At surgery)
Usability Information: Sound Processor Wearing Comfort(At 4 weeks, 6 weeks, 3 months and 6 months after surgery)
Usability Information: Daily Use of Sound Processor(At 6 weeks, 3 months and 6 months after surgery)
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(Baseline before surgery, 4 weeks, 3 months and 6 months after surgery)
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(Baseline before surgery, 4 weeks, 3 months and 6 months after surgery)
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(Baseline before surgery, 4 weeks, 3 months and 6 months after surgery)