Hearing Loss, Conductive, Hearing Loss, Mixed
Conditions
Brief summary
Approximately thirty subjects with mixed or conductive hearing loss, meeting FDA-cleared candidacy criteria for the BONEBRIDGE, will be implanted and followed for three (3) months post-activation to assess safety and effectiveness of the BONEBRIDGE implant.
Interventions
DEVICEBONEBRIDGE
Bone Conduction Implant
Sponsors
Med-El Corporation
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
* Adults, 18 years of age or older at the time of implantation * Conductive or mixed hearing loss, defined as: * Conductive hearing loss with pure-tone average (PTA) for bone conduction thresholds better than or equal to 25 dB at 500, 1000, 2000 and 3000 Hz * Mixed hearing loss with PTA for bone conduction thresholds better than or equal to 45dB at 500, 1000, 2000, and 3000 Hz * Air-bone gap greater than or equal to 30 dB at 500, 1000, 2000, and 3000 Hz * Ability to benefit from amplification as defined by a monosyllabic (CNC) word score of 30% correct or better * Bilateral BONEBRIDGE can be considered if the difference in PTA for bone conduction thresholds is 10 dB or less between the right and left ears * Prior experience with acoustic or bone conduction hearing aids, unless candidate is unable to wear amplification for medical reasons * Able to complete testing materials in English * CT scan indicating the patient's anatomy is adequate to enable placement of the implant * Ability to undergo general anesthesia * Appropriate motivation and expectation levels * Stated willingness to comply with all study procedures for the duration of the study
Exclusion criteria
* Evidence that hearing loss is retrocochlear in origin * Skin or scalp condition precluding use of external audio processor * Suspected cognitive impairment or organic brain dysfunction
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number and Proportion of Subjects Experiencing Device Related Adverse Events | Up to three (3 months) post activation | Adverse events will be collected and reported throughout the duration of the study. |
| Percentage Change in AZ Bio Sentence Score in Noise | Baseline and 3 months post activation | Percent improvement in AZ Bio sentence in noise scores will be compared from baseline to 3 months post activation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage Change in CNC Word Score | Baseline and 3 months post activation | Percent improvement in CNC word scores will be compared from baseline to 3 months post activation. |
| Number of Subjects With Stable or Better Soundfield Thresholds | Baseline and 3 months post activation | The number of subjects with stable or better aided soundfield thresholds at 3 months post activation compared to baseline unaided soundfield thresholds |
| Number of Subjects With Better QuickSIN Signal-to-noise-ratio Performance | Baseline and 3 months post activation | The number of subjects with similar or better performance on the QuickSIN (Speech In Noise) task in the implanted ear compared to baseline performance |
| Number of Subjects With Stable Unaided Bone Conduction Thresholds | Baseline and 2 weeks post surgery | The number of subjects with stable bone conduction thresholds at the device activation interval compared to pre-operative bone conduction thresholds. |
Countries
Canada, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| BONEBRIDGE All subjects implanted with the transcutaneous bone conduction implant. | 8 |
| Total | 8 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
| Overall Study | Lost to Follow-up | 1 |
Baseline characteristics
| Characteristic | BONEBRIDGE |
|---|---|
| Age, Continuous | 47 years |
| Duration of hearing loss | 28.4 years |
| Region of Enrollment Canada | 5 participants |
| Region of Enrollment United States | 3 participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 8 |
| other Total, other adverse events | 1 / 8 |
| serious Total, serious adverse events | 1 / 8 |
Outcome results
Primary
Number and Proportion of Subjects Experiencing Device Related Adverse Events
Adverse events will be collected and reported throughout the duration of the study.
Time frame: Up to three (3 months) post activation
Population: One subject did not pursue surgery after baseline evaluation. This subject was removed from this analysis.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| BONEBRIDGE | Number and Proportion of Subjects Experiencing Device Related Adverse Events | 1 Participants |
Primary
Percentage Change in AZ Bio Sentence Score in Noise
Percent improvement in AZ Bio sentence in noise scores will be compared from baseline to 3 months post activation.
Time frame: Baseline and 3 months post activation
Population: One subject was lost to follow up after 1 month, and one subject did not participate in postoperative intervals due to an adverse event. These subjects were removed from this analysis.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| BONEBRIDGE | Percentage Change in AZ Bio Sentence Score in Noise | 42.2 percent improvement |
Secondary
Number of Subjects With Better QuickSIN Signal-to-noise-ratio Performance
The number of subjects with similar or better performance on the QuickSIN (Speech In Noise) task in the implanted ear compared to baseline performance
Time frame: Baseline and 3 months post activation
Population: One subject was lost to follow up after 1 month, and one subject did not participate in postoperative intervals due to an adverse event. These subjects were removed from this analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| BONEBRIDGE | Number of Subjects With Better QuickSIN Signal-to-noise-ratio Performance | 6 Participants |
Secondary
Number of Subjects With Stable or Better Soundfield Thresholds
The number of subjects with stable or better aided soundfield thresholds at 3 months post activation compared to baseline unaided soundfield thresholds
Time frame: Baseline and 3 months post activation
Population: One subject was lost to follow up after 1 month, one subject did not participate in postoperative intervals due to an adverse event, and sound field data was missing for one subject. These subjects were removed from this analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| BONEBRIDGE | Number of Subjects With Stable or Better Soundfield Thresholds | 5 Participants |
Secondary
Number of Subjects With Stable Unaided Bone Conduction Thresholds
The number of subjects with stable bone conduction thresholds at the device activation interval compared to pre-operative bone conduction thresholds.
Time frame: Baseline and 2 weeks post surgery
Population: One subject did not participate in postoperative intervals due to an adverse event. These subjects were removed from this analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| BONEBRIDGE | Number of Subjects With Stable Unaided Bone Conduction Thresholds | 7 Participants |
Secondary
Percentage Change in CNC Word Score
Percent improvement in CNC word scores will be compared from baseline to 3 months post activation.
Time frame: Baseline and 3 months post activation
Population: One subject was lost to follow up after 1 month, and one subject did not participate in postoperative intervals due to an adverse event. These subjects were removed from this analysis.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| BONEBRIDGE | Percentage Change in CNC Word Score | 38.3 percent improvement |