Hearing Loss, ConductiveNCT03859648
BONEBRIDGE Bone Conduction Implant in Adults
A study testing BONEBRIDGE in people with Hearing Loss, Conductive and Hearing Loss, Mixed, run by Med-El Corporation at 3 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hearing Loss, Conductive, Hearing Loss, Mixed
- What is being tested?
- BONEBRIDGE
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 26 Aug 2019to 4 Nov 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 13Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
United States2 sites
The Ohio State Wexner Medical Center University
Columbus, Ohio, 43081
The Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: Outcomes in Adults With Mixed or Conductive Hearing Loss Implanted With the BONEBRIDGE
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.
- Conditions
- Hearing Loss, Conductive, Hearing Loss, Mixed
- Being tested
- BONEBRIDGE
- Medical subject headings
- Hearing Loss, Conductive, Hearing Loss, Mixed Conductive-Sensorineural
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BONEBRIDGEDevice
Bone Conduction Implant
| Study group | Role | What they receive |
|---|---|---|
| Bone Conduction Implant | Experimental | All subjects will be implanted with the bone conduction implant. Receives: Device: BONEBRIDGE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number and Proportion of Subjects Experiencing Device Related Adverse Events
Adverse events will be collected and reported throughout the duration of the study.
Measured: 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.
Measured: Baseline and 3 months post activation
Secondary outcomes (4)
Percentage Change in CNC Word Score
Percent improvement in CNC word scores will be compared from baseline to 3 months post activation.
Measured: Baseline and 3 months post activation
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
Measured: 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
Measured: 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.
Measured: Baseline and 2 weeks post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2019
- Study start26 Aug 2019
- Primary completion4 Nov 2022
- Study completion4 Nov 2022
Why it stopped: Slow enrollment due to COVID-19
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Hearing Loss, ConductiveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Med-El Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03859648
- Sponsor's protocol ID
- MED-EL BB
- Status last verified
- May 2024
- First submitted
- 12 Feb 2019
- Last updated
- 30 May 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 16868513Riss 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.
PubMed 25142577Schmerber 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.
PubMed 27475796Sprinzl 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.
PubMed 26073720Sprinzl 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.
PubMed 23714710Zernotti ME, Sarasty AB. Active Bone Conduction Prosthesis: Bonebridge(TM). Int Arch Otorhinolaryngol. 2015 Oct;19(4):343-8. doi: 10.1055/s-0035-1564329.
PubMed 26491482
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes in Adults With Mixed or Conductive Hearing Loss Implanted With the BONEBRIDGE
- ClinicalTrials.gov ID
- NCT03859648
- Acronym / sponsor ID
- MED-EL BB
- Conditions
- Hearing Loss, Conductive, Hearing Loss, Mixed
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow enrollment due to COVID-19
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Med-El CorporationIndustry (pharma, biotech, devices)
- Study start
- 26 Aug 2019 (actual)
- Primary completion
- 4 Nov 2022 (actual)
- Study completion
- 4 Nov 2022 (actual)
- First posted
- 1 Mar 2019 (actual)
- Results
- Posted 30 May 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bone Conduction Implant | Experimental | Device: BONEBRIDGEAll subjects will be implanted with the bone conduction implant. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BONEBRIDGEBone Conduction Implant | Device | Bone Conduction Implant |
Primary outcome
Number and Proportion of Subjects Experiencing Device Related Adverse Events
Time frame: 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
Time frame: 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.
4 secondary outcomes
Percentage Change in CNC Word Score
Time frame: Baseline and 3 months post activation
Number of Subjects With Stable or Better Soundfield Thresholds
Time frame: Baseline and 3 months post activation
Number of Subjects With Better QuickSIN Signal-to-noise-ratio Performance
Time frame: Baseline and 3 months post activation
Number of Subjects With Stable Unaided Bone Conduction Thresholds
Time frame: Baseline and 2 weeks post surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 16868513Badran 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.
- Background: PubMed 25142577Riss 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.
- Background: PubMed 27475796Schmerber 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.
- Background: PubMed 26073720Sprinzl 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.
- Background: PubMed 23714710Sprinzl 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.
- Background: PubMed 26491482Zernotti ME, Sarasty AB. Active Bone Conduction Prosthesis: Bonebridge(TM). Int Arch Otorhinolaryngol. 2015 Oct;19(4):343-8. doi: 10.1055/s-0035-1564329.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BONEBRIDGE in people with Hearing Loss, Conductive and Hearing Loss, Mixed, run by Med-El Corporation at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 30 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 May 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number and Proportion of Subjects Experiencing Device Related Adverse Events (time frame: Up to three (3 months) post activation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03859648, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2024.