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

Cochlear29 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Hearing Loss

Interventions

Osia 2 systemDEVICE

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (3)

Sydney Cochlear Implant Centre

Gladesville, Australia

The Royal Victorian Eye and Ear Hospital

Melbourne, Australia

Department of Otorhinolaryngology, Head and Neck Surgery Faculty of Medicine. The Chinese University of Hong Kong

Hong Kong, Hong Kong

Outcomes

Primary Outcomes

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)

Time frame: Baseline before surgery, 3 months after surgery

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

Time frame: Baseline before surgery, 3 months after surgery

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

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

Time frame: 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

Speech-to-noise ratio, 50% speech understanding

Time frame: Baseline before surgery, 4 weeks 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

Free-field \[0.25, 0.5, 0.75, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0 and 8.0 kHz\]

Time frame: Baseline before surgery, 4 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 Speech Recognition in Quiet

Data from ClinicalTrials.gov

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% correctly perceived words at 50dB, 65dB and 80dB SPL

Time frame: Baseline before surgery, 4 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

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.

Time frame: 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

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.

Time frame: Baseline before surgery, 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

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.

Time frame: Baseline before surgery, 3 months and 6 months after surgery

Surgical Information: Soft Tissue Thickness

Measured in mm

Time frame: Baseline before surgery or at surgery

Surgical Information: Surgery Time

Time in minutes between first incision to last suture

Time frame: At surgery

Surgical Information: Bone Polishing/Removal at the Actuator Site

Yes/No

Time frame: At surgery

Surgical Information: BI300 Implant Length

3 mm/4 mm

Time frame: At surgery

Surgical Information: Location of BI300 Implant

Measured in mm between the ear canal and the center of the actuator

Time frame: At surgery

Surgical Information: Type of Anesthesia

General/local

Time frame: At surgery

Surgical Information: Soft Tissue Reduction

Yes/No

Time frame: At surgery

Surgical Information: Surgical Incision Type

Examples: C-shaped/S-shaped/straight

Time frame: At surgery

Surgical Information: Location of the Surgical Incision in Relation to the Actuator

Anterior/posterior

Time frame: At surgery

Surgical Information: Estimated Length of the Surgical Incision

Measured in mm

Time frame: At surgery

Surgical Information: Placement of the Coil

Periosteal pocket (under periosteal)/on top of periosteum/on top of muscle)

Time frame: At surgery

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.

Time frame: At 4 weeks, 6 weeks, 3 months and 6 months after surgery

Usability Information: Sound Processor Retention

Assessed via a Visual Analog Scale 100 mm where 0 mm represents insufficient retention and 100 mm excellent retention

Time frame: At 4 weeks, 6 weeks, 3 months and 6 months after surgery

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

Time frame: At 4 weeks, 6 weeks, 3 months and 6 months after surgery

Usability Information: Use of SoftWear Pad

Yes/No

Time frame: At 6 weeks, 3 months and 6 months after surgery

Usability Information: Daily Use of Sound Processor

Average hours of daily use

Time frame: At 6 weeks, 3 months and 6 months after surgery

Usability Information: Daily Streaming Time of Sound Processor

Average hours of daily streaming

Time frame: At 6 weeks, 3 months and 6 months after surgery

Usability Information: Battery Lifetime of Sound Processor

Average hours of battery lifetime

Time frame: 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 Audiometric Thresholds

Free-field \[Pure Tone Average (PTA) 4, Mean of 0.5, 1, 2 and 4 kHz\].

Time frame: Baseline before surgery, 4 weeks, 3 months and 6 months after surgery

Free-field \[0.25, 0.5, 0.75, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0 and 8.0 kHz\].

Time frame: Baseline before surgery, 4 weeks, 3 months and 6 months after surgery

Signal-to-noise ratio, 50% speech understanding

Time frame: Baseline before surgery, 4 weeks, 3 months and 6 months after surgery

% correctly perceived words at 50dB, 65dB and 80dB SPL

Time frame: 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

BC direct (0.25, 0.5, 0.75, 1.0, 1.5, 2.0, 3.0, 4.0 and 6.0 kHz)

Time frame: Baseline before surgery, 4 weeks, 3 months and 6 months after surgery