Not provided
Not provided
Not provided
Not provided
Not provided
Slow enrollment due to COVID-19
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bone Conduction Implant | Experimental | All subjects will be implanted with the bone conduction implant. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BONEBRIDGE | Device | Bone Conduction Implant |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number and Proportion of Subjects Experiencing Device Related Adverse Events | Adverse events will be collected and reported throughout the duration of the study. | Up to three (3 months) post activation |
| 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. | Baseline and 3 months post activation |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage Change in CNC Word Score | Percent improvement in CNC word scores will be compared from baseline to 3 months post activation. | Baseline and 3 months post activation |
| Number of Subjects With Stable or Better Soundfield Thresholds |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Ohio State Wexner Medical Center University | Columbus | Ohio | 43081 | United States | ||
| The Hospital of the University of Pennsylvania |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16868513 | Background | Badran K, Bunstone D, Arya AK, Suryanarayanan R, Mackinnon N. Patient satisfaction with the bone-anchored hearing aid: a 14-year experience. Otol Neurotol. 2006 Aug;27(5):659-66. doi: 10.1097/01.mao.0000226300.13457.a6. | |
| 25142577 | Background | Riss D, Arnoldner C, Baumgartner WD, Blineder M, Flak S, Bachner A, Gstoettner W, Hamzavi JS. Indication criteria and outcomes with the Bonebridge transcutaneous bone-conduction implant. Laryngoscope. 2014 Dec;124(12):2802-6. doi: 10.1002/lary.24832. Epub 2014 Aug 20. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | BONEBRIDGE | Subjects implanted with the transcutaneous bone conduction implant |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | BONEBRIDGE | All subjects implanted with the transcutaneous bone conduction implant. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number and Proportion of Subjects Experiencing Device Related Adverse Events | Adverse events will be collected and reported throughout the duration of the study. | One subject did not pursue surgery after baseline evaluation. This subject was removed from this analysis. | Posted | Count of Participants | Participants | Up to three (3 months) post activation |
|
|
Adverse events were collected from surgery through 3 months post-activation.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | BONEBRIDGE | All subjects implanted with the transcutaneous bone conduction implant. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Postoperative infection | Infections and infestations | Systematic Assessment | Postoperative infection |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Scalp sensitivity | Skin and subcutaneous tissue disorders | Systematic Assessment | Scalp sensitivity at implant site |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| MED-EL Corporation | MED-EL Corporation | 919-314-1437 | research.us@medel.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 20, 2019 | Mar 27, 2024 | Prot_SAP_000.pdf |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D006314 | Hearing Loss, Conductive |
| D046089 | Hearing Loss, Mixed Conductive-Sensorineural |
| ID | Term |
|---|---|
| D034381 | Hearing Loss |
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The number of subjects with stable or better aided soundfield thresholds at 3 months post activation compared to baseline unaided soundfield thresholds
| Baseline and 3 months post activation |
| 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 | Baseline and 3 months post activation |
| 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. | Baseline and 2 weeks post surgery |
| Philadelphia |
| Pennsylvania |
| 19104 |
| United States |
| London Health Sciences Centre | London | Ontario | N6A 5A5 | Canada |
| 27475796 | Background | Schmerber S, Deguine O, Marx M, Van de Heyning P, Sterkers O, Mosnier I, Garin P, Godey B, Vincent C, Venail F, Mondain M, Deveze A, Lavieille JP, Karkas A. Safety and effectiveness of the Bonebridge transcutaneous active direct-drive bone-conduction hearing implant at 1-year device use. Eur Arch Otorhinolaryngol. 2017 Apr;274(4):1835-1851. doi: 10.1007/s00405-016-4228-6. Epub 2016 Jul 30. |
| 26073720 | Background | Sprinzl GM, Wolf-Magele A. The Bonebridge Bone Conduction Hearing Implant: indication criteria, surgery and a systematic review of the literature. Clin Otolaryngol. 2016 Apr;41(2):131-43. doi: 10.1111/coa.12484. Epub 2016 Feb 4. |
| 23714710 | Background | Sprinzl G, Lenarz T, Ernst A, Hagen R, Wolf-Magele A, Mojallal H, Todt I, Mlynski R, Wolframm MD. First European multicenter results with a new transcutaneous bone conduction hearing implant system: short-term safety and efficacy. Otol Neurotol. 2013 Aug;34(6):1076-83. doi: 10.1097/MAO.0b013e31828bb541. |
| 26491482 | Background | Zernotti ME, Sarasty AB. Active Bone Conduction Prosthesis: Bonebridge(TM). Int Arch Otorhinolaryngol. 2015 Oct;19(4):343-8. doi: 10.1055/s-0035-1564329. |
| years |
|
| Sex: Female, Male | This information was not collected from any participant. | Count of Participants | Participants |
|
| Race (NIH/OMB) | Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Duration of hearing loss | Mean | Full Range | years |
|
|
| 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. | 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. | Posted | Mean | Full Range | percent improvement | Baseline and 3 months post activation |
|
|
|
| Secondary | Percentage Change in CNC Word Score | Percent improvement in CNC word scores will be compared from baseline to 3 months post activation. | 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. | Posted | Mean | Full Range | percent improvement | Baseline and 3 months post activation |
|
|
|
| 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 | 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. | Posted | Number | Participants | Baseline and 3 months post activation |
|
|
|
| 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 | 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. | Posted | Number | Participants | Baseline and 3 months post activation |
|
|
|
| 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. | One subject did not participate in postoperative intervals due to an adverse event. These subjects were removed from this analysis. | Posted | Number | Participants | Baseline and 2 weeks post surgery |
|
|
|
| 0 |
| 8 |
| 1 |
| 8 |
| 1 |
| 8 |
|
|
Not provided
Not provided
| D012678 |
| Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |