Conductive Hearing Loss, Mixed Hearing Loss
Conditions
Keywords
conductive hearing loss, mixed hearing loss
Brief summary
To evaluate the clinical efficacy of the Osia 2 system in patients with conductive or mixed conductive hearing loss in a US cohort.
Interventions
DEVICEOsia 2 System
The external Sound Processor, Osia 2 Active Osseointegrated Implant System for Bone Conduction, captures and digitizes the sound which is transferred to the internal implant where it is converted to an electrical signal.
Sponsors
Cochlear
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Willing and able to provide written informed consent. * Proficient in English. * Hearing loss etiology of Conductive or Mixed Conductive loss. * Bone conduction PTA (.5, 1, 2, and 3 kHz) better than or equal to 55 dB HL in the treatment ear. * Aged 18 years and older.
Exclusion criteria
* Unwilling to wear the treatment device or comply with the surgical and rehabilitation requirements of the study. * Unable or unwilling to comply with the requirements of the clinical investigation as determined by the Investigator. * Medical, audiological or psychological conditions, as judged by the investigator that might contraindicate participation in the clinical investigation. * 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 contractors engaged by Cochlear for the purposes of this investigation. * Currently participating, or participated within the last 30 days, in another interventional clinical investigation/trial involving an investigational drug or device. * Prior experience with a surgical bone conduction treatment option * Insufficient bone quality to support the BI300 implant as determined by the surgeon
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Adaptive Speech in Noise Test Score for Osia 2 System at 3 Months Post-surgery | Preoperative, 3 months post-surgery | Assessed with the Quick SIN test preoperative and at 3 months post-surgery. The Quick SIN test has a score range from +25.5 dB (decibel) SNR (signal-to-noise ratio) to -5 dB SNR. The participants are tested on 4 tests lists; each consists of 6 sentences (with 5 key words per sentence) that are presented at signal-to-noise ratios (SNR) which are decreased manually in 5-dB steps from 25 to 0. The key words in sentences are scored and counted as correct from an easy to difficult or unfavorable SNR. The best possible score on this test would be that of -5 dB SNR where all of the key words are repeated back correctly as a function of the SNR. The mean unaided preoperative score is substracted from the aided score at 3 months. A lower score indicates a better performance. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Device or Procedure Related Adverse Events | 6 months post-surgery | A device or procedure related adverse event (AE) is an AE for which a causal relationship between the use of the medical device and the AE cannot be ruled out. All related AEs are reported. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Osia 2 System Osia 2 Active Osseointegrated Implant System for Bone Conduction
Osia 2 System: The external Sound Processor, Osia 2 Active Osseointegrated Implant System for Bone Conduction, captures and digitizes the sound which is transferred to the internal implant where it is converted to an electrical signal. | 20 |
| Total | 20 |
Baseline characteristics
| Characteristic | Osia 2 System |
|---|---|
| Age, Continuous | 47.9 years STANDARD_DEVIATION 16.2 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 17 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Race (NIH/OMB) White | 17 Participants |
| Region of Enrollment United States | 20 participants |
| Sex: Female, Male Female | 12 Participants |
| Sex: Female, Male Male | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 20 |
| other Total, other adverse events | 7 / 20 |
| serious Total, serious adverse events | 0 / 20 |
Outcome results
Primary
Change From Baseline in Adaptive Speech in Noise Test Score for Osia 2 System at 3 Months Post-surgery
Assessed with the Quick SIN test preoperative and at 3 months post-surgery. The Quick SIN test has a score range from +25.5 dB (decibel) SNR (signal-to-noise ratio) to -5 dB SNR. The participants are tested on 4 tests lists; each consists of 6 sentences (with 5 key words per sentence) that are presented at signal-to-noise ratios (SNR) which are decreased manually in 5-dB steps from 25 to 0. The key words in sentences are scored and counted as correct from an easy to difficult or unfavorable SNR. The best possible score on this test would be that of -5 dB SNR where all of the key words are repeated back correctly as a function of the SNR. The mean unaided preoperative score is substracted from the aided score at 3 months. A lower score indicates a better performance.
Time frame: Preoperative, 3 months post-surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Osia 2 System | Change From Baseline in Adaptive Speech in Noise Test Score for Osia 2 System at 3 Months Post-surgery | 6.1 Score on a scale | Standard Deviation 6.9 |
Secondary
Number of Device or Procedure Related Adverse Events
A device or procedure related adverse event (AE) is an AE for which a causal relationship between the use of the medical device and the AE cannot be ruled out. All related AEs are reported.
Time frame: 6 months post-surgery
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Osia 2 System | Number of Device or Procedure Related Adverse Events | 15 Number of events |