Hearing LossNCT04611698
Immediate Loading of Bone Anchored Hearing Devices
A study testing Baha sound processor BA400 in people with Hearing Loss, run by Manchester University NHS Foundation Trust.
Trial summary
Bone anchored hearing aids provide a hearing solution for patients that are unable to wear traditional air conduction hearing aid solutions. The technology of the devices has developed significantly over the last 510 years and patients are gaining access to their sound processor at a much earlier stage than when first… Read more about this study
- Who is it for?
- Ages 18 to 110 years
- Conditions the study is for
- Hearing Loss
- What is being tested?
- Baha sound processor BA400
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- No sites listed yet
- Study dates
- Jun 2016to 31 Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 110 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients eligible for receiving the Baha system.
Who cannot join
- Adult patients, i.e. ≥18 years
- Eligible for the Baha system
- Bone thickness at the implant site of at least 4 mm
- No known disease or treatment that compromises / will compromise the bone quality at the implant site
About this study
Bone anchored hearing aids provide a hearing solution for patients that are unable to wear traditional air conduction hearing aid solutions. The technology of the devices has developed significantly over the last 510 years and patients are gaining access to their sound processor at a much earlier stage than when first brought onto the market. Despite this the investigators feel there is still room to develop this and with the new abutments with specialised hydroxyapatite coating it is hoped that patients can be loaded with their sound processor in the day of surgery. This study will compare abutment stability between two groups of patients. Those loaded immediately with their sound processor and those loaded traditionally at 2 weeks post operatively.
At routine followup appointments patients will have the stability of their abutment checked and the investigators will compare to see if loading earlier had any detrimental effects on osteointegration and the stability of the abutment.
Based on the favourable outcomes and high stability record for the BA400 it is anticipated that the time to processor fitting may be further reduced, provided favourable bone conditions at the implant site and provided satisfactory soft tissue status at the time of loading. It is hypothesised that loading immediately at the time of surgery is possible with comparable short and long term outcomes when compared to standard loading at 2 weeks
- Conditions
- Hearing Loss
- Being tested
- Baha sound processor BA400
- Medical subject headings
- Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Baha sound processor BA400Device
Baha sound processor BA400 is a cochlear implant designed specifically for soft tissue preservation.
| Study group | Role | What they receive |
|---|---|---|
| Immediate loading group | Experimental | Visit 1 Implant surgery + Device loading Baseline Visit 2 Followup examination 2 weeks (2/+ 5 days) Visit 3 Followup examination 3 months (± 1 week) Visit 4 Followup examination 6 months (± 1 week) Visit 5 Followup examination 12 months (± 1 month) Receives: Device: Baha sound processor BA400 |
| 2-week loading group | Experimental | Visit 1 Implant surgery Baseline Visit 2 Device loading 2 weeks (2/+5 days) Visit 3 Followup examination 3 months (± 1 week) Visit 4 Followup examination 6 months (± 1 week) Visit 5 Followup examination 12 months (± 1 month) Receives: Device: Baha sound processor BA400 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare device stability and rate of successful implantation
Measuring device stability and rate of successful implantation for patients fitted with the Baha BA400 immediately on the day of surgery and at fitting 2 weeks post operatively. A successful implant is an implant that osseointegrates and is stable over time when supporting the load of the Baha sound processor.
Measured: 12 months
Secondary outcomes (3)
Measure the stability, as determined by Implant Stability Quotient (ISQ) values, of Baha implants placed immediately and at 23 weeks post operatively.
Measured: 23 weeks
Record implant survival over time.
Measured: 12 months
Monitor the status of the periimplant soft tissue using the classification proposed by Holgers' et al.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2020
- Study startJun 2016
- Primary completionJun 2017
- Study completion31 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hearing LossStudies 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
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Manchester University NHS Foundation Trust
- Sponsor type
- Other government
- Collaborators
- Northern Care Alliance NHS Foundation Trust
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04611698
- Sponsor's protocol ID
- R03963
- Status last verified
- Apr 2023
- First submitted
- 22 Oct 2020
- Last updated
- 25 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immediate Loading of Bone Anchored Hearing Devices
- ClinicalTrials.gov ID
- NCT04611698
- Acronym / sponsor ID
- R03963
- Conditions
- Hearing Loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Manchester University NHS Foundation TrustOther government
- Collaborators
- Northern Care Alliance NHS Foundation Trust
- Study start
- Jun 2016 (actual)
- Primary completion
- Jun 2017 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 2 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Bone anchored hearing aids provide a hearing solution for patients that are unable to wear traditional air conduction hearing aid solutions. The technology of the devices has developed significantly over the last 510 years and patients are gaining access to their sound processor at a much earlier stage than when first brought onto the market. Despite this the investigators feel there is still room to develop this and with the new abutments with specialised hydroxyapatite coating it is hoped that patients can be loaded with their sound processor in the day of surgery. This study will compare abutment stability between two groups of patients. Those loaded immediately with their sound processor and those loaded traditionally at 2 weeks post operatively.
At routine followup appointments patients will have the stability of their abutment checked and the investigators will compare to see if loading earlier had any detrimental effects on osteointegration and the stability of the abutment.
Based on the favourable outcomes and high stability record for the BA400 it is anticipated that the time to processor fitting may be further reduced, provided favourable bone conditions at the implant site and provided satisfactory soft tissue status at the time of loading. It is hypothesised that loading immediately at the time of surgery is possible with comparable short and long term outcomes when compared to standard loading at 2 weeks
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immediate loading group | Experimental | Device: Baha sound processor BA400Visit 1 Implant surgery + Device loading Baseline Visit 2 Followup examination 2 weeks (2/+ 5 days) Visit 3 Followup examination 3 months (± 1 week) Visit 4 Followup examination 6 months (± 1 week) Visit 5 Followup examination 12 months (± 1 month) |
| 2-week loading group | Experimental | Device: Baha sound processor BA400Visit 1 Implant surgery Baseline Visit 2 Device loading 2 weeks (2/+5 days) Visit 3 Followup examination 3 months (± 1 week) Visit 4 Followup examination 6 months (± 1 week) Visit 5 Followup examination 12 months (± 1 month) |
Who may qualify
- Ages
- 18 to 110 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients eligible for receiving the Baha system.
Key exclusion criteria (4 listed)
- Adult patients, i.e. ≥18 years
- Eligible for the Baha system
- Bone thickness at the implant site of at least 4 mm
- No known disease or treatment that compromises / will compromise the bone quality at the implant site
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 |
|---|---|---|
| Baha sound processor BA400Baha sound processor BA400 is a cochlear implant designed specifically for soft tissue preservation. | Device | 2-week loading group, Immediate loading group |
Primary outcome
Compare device stability and rate of successful implantation
Time frame: 12 months
Measuring device stability and rate of successful implantation for patients fitted with the Baha BA400 immediately on the day of surgery and at fitting 2 weeks post operatively. A successful implant is an implant that osseointegrates and is stable over time when supporting the load of the Baha sound processor.
3 secondary outcomes
Measure the stability, as determined by Implant Stability Quotient (ISQ) values, of Baha implants placed immediately and at 23 weeks post operatively.
Time frame: 23 weeks
Record implant survival over time.
Time frame: 12 months
Monitor the status of the periimplant soft tissue using the classification proposed by Holgers' et al.
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2023.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing Baha sound processor BA400 in people with Hearing Loss, run by Manchester University NHS Foundation Trust.
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 1 inclusion and 4 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: finished, as of the sponsor's last update on 25 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Compare device stability and rate of successful implantation (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Apr 2023.