Conductive Hearing Loss, Mixed Hearing Loss, Single-Sided Deafness
Conditions
Brief summary
The CochlearTM Osia®2 System was cleared by the Food and Drug Administration November 15, 2019 (K191921) for individuals aged 12 years and older who present with conductive or mixed hearing loss (up to 55 dB HL) or single-sided-deafness (SSD).Published and unpublished data suggest significant pre to postoperative benefit and minimal risk in both children and adults who have received the Osia system. Thus the objective of this study is to examine the safety and effectiveness of the Cochlear Osia 2 system in a group of pediatric subjects aged 5 to 11 years who suffer from conductive or mixed hearing loss (up to 55 dB HL), or single-sided-deafness (SSD) with the intent of expanding the indications for use.
Detailed description
The CochlearTM Osia®2 System was cleared by the Food and Drug Administration November 15, 2019 (K191921) for individuals aged 12 years and older who present with conductive or mixed hearing loss (up to 55 dB HL) or single-sided-deafness (SSD). Published and unpublished data suggest significant pre to postoperative benefit and minimal risk in both children and adults who have received the Osia system. Due to the success of the Osia 2 system in the United States within the currently indicated patient population, clinical providers have since requested the ability to use the Osia 2 system in children aged 11 years and younger who meet the audiometric requirements. As the Osia 2 system is based on existing bone conduction and cochlear implant technologies which each possess a younger age of implantation requirement (5 years for bone conduction and 9 months for cochlear implantation), the current proposal is to align the age at implantation requirement with existing surgical bone conduction technology such as the Baha Connect and Baha Attract Systems to 5 years of age. Therefore, the objective of this study is to examine the safety and effectiveness of the Cochlear Osia 2 system in a group of pediatric subjects aged 5 to 11 years who suffer from conductive or mixed hearing loss (up to 55 dB HL), or single-sided-deafness (SSD) with the intent of expanding the indications for use.
Interventions
DEVICEOsia 2 System
Osia 2 System in a pediatric population aged 5 - 11 years by quantifying the type, frequency and severity of adverse events.
Sponsors
R. P. Chiacchierini Consulting, LLC
Analytical Solutions Group, Inc.
Cochlear
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
5 Years to 11 Years
Healthy volunteers
No
Inclusion criteria
1. Subjects aged 5 to 11 years of age with the following audiometric criterion: * A conductive or mixed hearing loss and still can benefit from sound amplification. The pure tone average (PTA) bone conduction (BC) threshold (measured at 0.5, 1, 2, and 3 kHz) should be better than or equal to 55 dB HL. OR * A profound sensorineural hearing loss in one ear and normal hearing in the opposite ear (i.e., single-sided deafness or SSD). The pure tone average air conduction hearing thresholds of the hearing ear should be better than or equal to 20 dB HL (measured at 0.5, 1, 2, and 3 kHz). 2. Prior experience with amplified sound through properly fitted amplification device such as a hearing aid, a CROS device, or a bone conduction device on a softband or sound arc. 3. Parent or legal guardian who is willing and able to provide written informed consent for the study participant. Note: Subjects may include individuals seeking new implantation unilaterally (in one ear) or individuals already implanted with a bone-anchored device seeking a second-side implant (sequential bilateral)
Exclusion criteria
1. Insufficient bone quality or quantity to support implantation of both the BI300 Implant and the OSI200 Implant. 2. Chronic or non-revisable vestibular or balance disorders that could prevent benefit from the device, as determined by the investigator. 3. Abnormally progressive hearing loss. 4. Evidence that hearing loss is bilateral retro cochlear or bilateral central origin. 5. Evidence of conditions that would prevent speech recognition improvement as determined by the investigator. 6. Skin or scalp conditions that may preclude attachment of the Sound Processor or that may interfere with the use of the Sound Processor. 7. Unable or unwilling to comply with the requirements of the clinical investigation as determined by the Investigator. 8. Investigator site personnel directly affiliated with this study and/or their immediate families; immediate family is defined as a spouse, parent, child, or sibling. 9. Cochlear employees or employees of Contract Research Organizations or contractors engaged by Cochlear for the purposes of this investigation. 10. Currently participating, or participated within the last 30 days, in another clinical investigation involving an investigational drug or device that could impact the safety or effectiveness of the Osia 2 system as determined by the investigator. 11. Individuals undergoing simultaneous single-stage aural atresia or microtia repair due to the increased risk of skin complications associated with ear reconstruction.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Adverse Events Quantified by Type and Severity Between Implantation and 6-months Post-surgery. | From implantation to 6 months post-surgery | Adverse events were reported from the time of implantation through 6-months. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline to 6-months Post-surgery in SSQ (Speech, Spatial and Qualities of Hearing Scale) Parent Questionnaire | Baseline before surgery, 6 months post-surgery | Measuring change of speech, spatial, quality and conversational uses of hearing (27 items in 4 sections). Each item is scored by the parent on a scale of 0 to 10 where 0 corresponds to not at all and 10 to perfectly when rating their child's ability to hear and listen in everyday situations. The score of a participant is determined as the mean of the scores for the 4 different sections. Higher scores indicate less hearing disability. |
| Change From Baseline to 4-weeks Post-surgery in Unaided Bone Conduction Thresholds. | Baseline before surgery, 4 weeks post-surgery | The Pure Tone Average (PTA) is calculated as an average of the bone conduction thresholds collected at 500, 1000, 2000, and 4000 Hz. This measure was collected unaided both pre- and post-operatively to ensure no shift in bone conduction hearing as a result of the surgery. |
| Change in Word Recognition Using Consonant Nucleus Consonant (CNC) Words Presented in Quiet From Unaided Baseline to Aided 6-months Post-surgery. | Baseline before surgery, 6 months post-surgery | The CNC Words test consists of 10 recorded lists of 50 monosyllabic words. For this study, one list is administered per test condition at 60 dBA in sound field and scored as the number of phonemes and words correct, which will be expressed as a percentage correct when analyzed. The CNC word test has a score range of 0-100% with higher values indicating better scores. |
| Change in Sentence Recognition in Noise Using the Bramford Kowal Bench Speech-In-Noise (BKB-SIN) From Unaided Baseline to Aided 6-months Post-surgery. | Baseline before surgery, 6 months post-surgery | The Bamford-Kowal-Bench Sentence in Noise test (BKB-SIN) consists of 36 paired lists. List of sentences are presented at 65 dBA with the level of noise varied stepwise at fixed signal to noise ratio to obtain a Speech Reception Threshold (SRT) where participants are able to repeat key words 50% of the time. Score range is not specified as metric is adaptive; lower scores indicate better performance. |
Countries
United States
Participant flow
Recruitment details
Participants were recruited at seven US-based sites. The first participant was enrolled on 26 January 2022 and the last participant completed the study on 14 March 2024.
Participants by arm
| Arm | Count |
|---|---|
| Implanted With the Osia 2 System Osia 2 System in a pediatric population aged 5 - 11 years. | 50 |
| Total | 50 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 1 |
Baseline characteristics
| Characteristic | Implanted With the Osia 2 System |
|---|---|
| Age, Continuous | 7 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 19 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 30 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 2 Participants |
| Race/Ethnicity, Customized Asian | 4 Participants |
| Race/Ethnicity, Customized Black or African American | 2 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Pacific Islander | 0 Participants |
| Race/Ethnicity, Customized Other | 6 Participants |
| Race/Ethnicity, Customized Unknown or Not Reported | 3 Participants |
| Race/Ethnicity, Customized White | 33 Participants |
| Region of Enrollment United States | 50 participants |
| Sex: Female, Male Female | 23 Participants |
| Sex: Female, Male Male | 27 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 49 |
| other Total, other adverse events | 23 / 49 |
| serious Total, serious adverse events | 7 / 49 |
Outcome results
Primary
Number of Adverse Events Quantified by Type and Severity Between Implantation and 6-months Post-surgery.
Adverse events were reported from the time of implantation through 6-months.
Time frame: From implantation to 6 months post-surgery
Population: 1 participant withdrew after the 4-week follow-up visit.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Implanted With the Osia 2 System | Number of Adverse Events Quantified by Type and Severity Between Implantation and 6-months Post-surgery. | Adverse Device Effects | 32 Number of events |
| Implanted With the Osia 2 System | Number of Adverse Events Quantified by Type and Severity Between Implantation and 6-months Post-surgery. | Serious Adverse Events | 8 Number of events |
| Implanted With the Osia 2 System | Number of Adverse Events Quantified by Type and Severity Between Implantation and 6-months Post-surgery. | Serious Adverse Device Effects | 3 Number of events |
| Implanted With the Osia 2 System | Number of Adverse Events Quantified by Type and Severity Between Implantation and 6-months Post-surgery. | Unanticipated Adverse Device Effects | 0 Number of events |
| Implanted With the Osia 2 System | Number of Adverse Events Quantified by Type and Severity Between Implantation and 6-months Post-surgery. | Mild Events | 73 Number of events |
| Implanted With the Osia 2 System | Number of Adverse Events Quantified by Type and Severity Between Implantation and 6-months Post-surgery. | Moderate Events | 10 Number of events |
| Implanted With the Osia 2 System | Number of Adverse Events Quantified by Type and Severity Between Implantation and 6-months Post-surgery. | Sever Events | 4 Number of events |
Secondary
Change From Baseline to 4-weeks Post-surgery in Unaided Bone Conduction Thresholds.
The Pure Tone Average (PTA) is calculated as an average of the bone conduction thresholds collected at 500, 1000, 2000, and 4000 Hz. This measure was collected unaided both pre- and post-operatively to ensure no shift in bone conduction hearing as a result of the surgery.
Time frame: Baseline before surgery, 4 weeks post-surgery
Population: 3 participants were unable to be included due to improper testing pre- and post-operatively.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Implanted With the Osia 2 System | Change From Baseline to 4-weeks Post-surgery in Unaided Bone Conduction Thresholds. | 0.1 dB HL (decibel Hearing Level) | Standard Deviation 5.1 |
Secondary
Change From Baseline to 6-months Post-surgery in SSQ (Speech, Spatial and Qualities of Hearing Scale) Parent Questionnaire
Measuring change of speech, spatial, quality and conversational uses of hearing (27 items in 4 sections). Each item is scored by the parent on a scale of 0 to 10 where 0 corresponds to not at all and 10 to perfectly when rating their child's ability to hear and listen in everyday situations. The score of a participant is determined as the mean of the scores for the 4 different sections. Higher scores indicate less hearing disability.
Time frame: Baseline before surgery, 6 months post-surgery
Population: One participant withdrew prior to the 6-month visit. One participant was unable to complete the questionnaire during the 6-month visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Implanted With the Osia 2 System | Change From Baseline to 6-months Post-surgery in SSQ (Speech, Spatial and Qualities of Hearing Scale) Parent Questionnaire | 1.63 score on a scale | Standard Deviation 1.53 |
Secondary
Change in Sentence Recognition in Noise Using the Bramford Kowal Bench Speech-In-Noise (BKB-SIN) From Unaided Baseline to Aided 6-months Post-surgery.
The Bamford-Kowal-Bench Sentence in Noise test (BKB-SIN) consists of 36 paired lists. List of sentences are presented at 65 dBA with the level of noise varied stepwise at fixed signal to noise ratio to obtain a Speech Reception Threshold (SRT) where participants are able to repeat key words 50% of the time. Score range is not specified as metric is adaptive; lower scores indicate better performance.
Time frame: Baseline before surgery, 6 months post-surgery
Population: One participant withdrew prior to the 6-month visit. One participant was unable to complete the BKB-SIN testing during the baseline visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Implanted With the Osia 2 System | Change in Sentence Recognition in Noise Using the Bramford Kowal Bench Speech-In-Noise (BKB-SIN) From Unaided Baseline to Aided 6-months Post-surgery. | 10.1 db SNR (decibel Speech to Noise Ratio) | Standard Deviation 7.8 |
Secondary
Change in Word Recognition Using Consonant Nucleus Consonant (CNC) Words Presented in Quiet From Unaided Baseline to Aided 6-months Post-surgery.
The CNC Words test consists of 10 recorded lists of 50 monosyllabic words. For this study, one list is administered per test condition at 60 dBA in sound field and scored as the number of phonemes and words correct, which will be expressed as a percentage correct when analyzed. The CNC word test has a score range of 0-100% with higher values indicating better scores.
Time frame: Baseline before surgery, 6 months post-surgery
Population: One participant withdrew prior to the 6-month visit. One participant was unable to complete the CNC word test during the baseline visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Implanted With the Osia 2 System | Change in Word Recognition Using Consonant Nucleus Consonant (CNC) Words Presented in Quiet From Unaided Baseline to Aided 6-months Post-surgery. | 63.7 percentage of correct words | Standard Deviation 24.6 |