Clinical Performance, Safety and Patient Reported Outcomes of an Active Osseointegrated Steady-State Implant System

Hearing Loss Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04041700
• Other study ID #: CBAS5751
• Status: Completed
• Phase: N/A
• Start date: August 16, 2019
• Est. completion date: September 24, 2020

Study information

• Verified date: July 2021
• Source: Cochlear
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: September 24, 2020
• Est. primary completion date: June 19, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Deafness
• Hearing Loss

Intervention

Device:
• Osia 2 system
System includes the OSI200 implant surgically placed under the skin behind the ear, the BI300 implant osseointegrated in the bone and the external Osia 2 sound processor.

Locations

Country	Name	City	State
Australia	Sydney Cochlear Implant Centre	Gladesville
Australia	The Royal Victorian Eye and Ear Hospital	Melbourne
Hong Kong	Department of Otorhinolaryngology, Head and Neck Surgery Faculty of Medicine. The Chinese University of Hong Kong	Hong Kong

Sponsors (2)

Lead Sponsor	Collaborator
Cochlear	Statistiska Konsultgruppen

Countries where clinical trial is conducted

Australia,  Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Hearing Performance With the Osia 2 System at 3 Months Post-surgery Compared to Preoperative Unaided Condition Assessed Via Audiometric Thresholds	Free field (Pure Tone Average 4, mean of 0.5, 1,2 and 4 kHz)	Baseline before surgery, 3 months after surgery
Primary	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	Speech-to-noise ratio, 50% speech understanding	Baseline before surgery, 3 months after surgery
Secondary	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	Free field (Pure Tone Average 4, mean of 0.5, 1,2 and 4 kHz)	Baseline before surgery, 4 weeks and 6 months after surgery
Secondary	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	Speech-to-noise ratio, 50% speech understanding	Baseline before surgery, 4 weeks and 6 months after surgery
Secondary	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	Free-field [0.25, 0.5, 0.75, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0 and 8.0 kHz]	Baseline before surgery, 4 weeks, 3 months and 6 months after surgery
Secondary	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	% correctly perceived words at 50dB, 65dB and 80dB SPL	Baseline before surgery, 4 weeks, 3 months and 6 months after surgery
Secondary	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	Measuring change of Ease of communication, Reverberation, Background noise, Aversiveness and a Global score with the Osia 2 System from the pre-operative unaided situation. The absolute APHAB scale is between 0 and 100%, where 0% indicates no problems and 100% indicates always problem. The change from unaided to aided hearing is presented. A positive value indicates an impairment, a negative value an improvement.	Baseline before surgery, 3 months and 6 months after surgery
Secondary	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	Measuring change of speech, spatial and hearing experiences with the Osia 2 System from the pe-operative unaided situation. A scale from 0 to 10 is used, where 0 represents "can not hear at all", and 10 "hear perfectly". The change from unaided to aided hearing is presented. A positive value indicates improved hearing, a negative value indicates impaired hearing.	Baseline before surgery, 3 months and 6 months after surgery
Secondary	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	Change of health status and health related quality of life using the generic quality of life scale Health Utilities Index (HUI3) when wearing Osia 2 System compared to the pre-operative unaided situation. A health utility value of 1.00 indicates perfect health while a score of 0.00 indicates death. The change from unaided to aided hearing is presented. A positive value indicates an improved quality of life, a negative value indicates impaired quality of life.	Baseline before surgery, 3 months and 6 months after surgery
Secondary	Surgical Information: Soft Tissue Thickness	Measured in mm	Baseline before surgery or at surgery
Secondary	Surgical Information: Surgery Time	Time in minutes between first incision to last suture	At surgery
Secondary	Surgical Information: Bone Polishing/Removal at the Actuator Site	Yes/No	At surgery
Secondary	Surgical Information: BI300 Implant Length	3 mm/4 mm	At surgery
Secondary	Surgical Information: Location of BI300 Implant	Measured in mm between the ear canal and the center of the actuator	At surgery
Secondary	Surgical Information: Type of Anesthesia	General/local	At surgery
Secondary	Surgical Information: Soft Tissue Reduction	Yes/No	At surgery
Secondary	Surgical Information: Surgical Incision Type	Examples: C-shaped/S-shaped/straight	At surgery
Secondary	Surgical Information: Location of the Surgical Incision in Relation to the Actuator	Anterior/posterior	At surgery
Secondary	Surgical Information: Estimated Length of the Surgical Incision	Measured in mm	At surgery
Secondary	Surgical Information: Placement of the Coil	Periosteal pocket (under periosteal)/on top of periosteum/on top of muscle)	At surgery
Secondary	Usability Information: Magnet Choice	Magnet strength ranging from 1 to 4 where 1 is the weakest and 4 the strongest. A magnet allows the external sound processor to be placed in the correct position over the implanted system including an internal magnet.	At 4 weeks, 6 weeks, 3 months and 6 months after surgery
Secondary	Usability Information: Sound Processor Retention	Assessed via a Visual Analog Scale 100 mm where 0 mm represents insufficient retention and 100 mm excellent retention	At 4 weeks, 6 weeks, 3 months and 6 months after surgery
Secondary	Usability Information: Sound Processor Wearing Comfort	Assessed via a Visual Analog Scale 100 mm where 0 mm represents no comfort at all and 100 mm excellent comfort	At 4 weeks, 6 weeks, 3 months and 6 months after surgery
Secondary	Usability Information: Use of SoftWear Pad	Yes/No	At 6 weeks, 3 months and 6 months after surgery
Secondary	Usability Information: Daily Use of Sound Processor	Average hours of daily use	At 6 weeks, 3 months and 6 months after surgery
Secondary	Usability Information: Daily Streaming Time of Sound Processor	Average hours of daily streaming	At 6 weeks, 3 months and 6 months after surgery
Secondary	Usability Information: Battery Lifetime of Sound Processor	Average hours of battery lifetime	At 6 weeks, 3 months and 6 months after surgery
Secondary	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	Free-field [Pure Tone Average (PTA) 4, Mean of 0.5, 1, 2 and 4 kHz].	Baseline before surgery, 4 weeks, 3 months and 6 months after surgery
Secondary	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	Free-field [0.25, 0.5, 0.75, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0 and 8.0 kHz].	Baseline before surgery, 4 weeks, 3 months and 6 months after surgery
Secondary	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	Signal-to-noise ratio, 50% speech understanding	Baseline before surgery, 4 weeks, 3 months and 6 months after surgery
Secondary	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	% correctly perceived words at 50dB, 65dB and 80dB SPL	Baseline before surgery, 4 weeks, 3 months and 6 months after surgery
Secondary	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	BC direct (0.25, 0.5, 0.75, 1.0, 1.5, 2.0, 3.0, 4.0 and 6.0 kHz)	Baseline before surgery, 4 weeks, 3 months and 6 months after surgery