Hearing LossNCT05058066
10-year Follow-up of a Wide Diameter Bone Anchored Hearing Implant
A study testing Baha® flange fixture (diameter 3.75mm; length 4mm) with 6mm abutment, Baha® BIA300 Implant (diameter 4.5mm; length 4mm) with 6mm abutment and Early loading in people with Hearing Loss, run by Radboud University Medical Center at 1 site in Netherlands.
Trial summary
A single centre, open, comparative, parallel group, prospective clinical investigation with a single 10 year follow up visit. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hearing Loss
- What is being tested?
- Baha® flange fixture (diameter 3.75mm; length 4mm) with 6mm abutment, Baha® BIA300 Implant (diameter 4.5mm; length 4mm) with 6mm abutment and Early loading
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteNetherlands
- Study dates
- 24 Jun 2019to 21 Sep 2020
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- To be included in the original trials, patients had to be at least 18 years old.
Who cannot join
- Exclusion criteria were an inability to follow investigational procedures, any factor at the discretion of the investigator that was considered to contraindicate participation, and any disease or treatment known to compromise the bone quality at the implant site. For patients who had lost or removed the implant, the time to implant loss was recorded. Patients who could not attend the 5 or 10 year follow-up visit for other reasons were included in the implant survival analysis as well; the last available information regarding implant survival was obtained verbally from the patient, from medical records, or from information captured from the original investigations. Furthermore, patients were excluded if they had a bone thickness less than 4 mm at the implant site during implantation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Long-term Follow-up of a Wide Diameter Bone Anchored Hearing Implant: the 10-year Experience on Stability, Survival and Tolerability of the BIA300®
A single centre, open, comparative, parallel group, prospective clinical investigation with a single 10 year follow up visit.
Read the detailed description
This study is a continuation of two previous conducted trials:
- Stability, long term survival and tolerability of a novel Baha® implant system, a multi-centre investigation new BIA300 (test) implant vs previous generation (control) implant:
- CAG5173: 6-month(1) and 3-year(2) data.
- CBAS5562: 5-year data(3).
- 3 weeks loading: stability, long term survival and tolerability of a novel Baha® implant system, a multi-centre investigation 3 week loading vs 6+ week loading (= same group as control group trial 1). 6- month(4) and 3-year(5) data.
In this study the (5-year data for trial 2 and) 10-year data regarding stability, survival and soft tissue tolerability from the above mentioned trials will be evaluated and compared. The previous trials were multicentre, but the current study will be single-centred and therefore only include the participants of the Radboud site. Data will be collected at a visit at (5 years, for trial 2 and) 10 years (+/- 6 months) after implantation.
Up to now, no RCT of these implants (with the loading of 3 weeks after implantation) has assessed stability, survival and tolerability over a 10-year follow-up period.
- Conditions
- Hearing Loss
- Being tested
- Baha® flange fixture (diameter 3.75mm; length 4mm) with 6mm abutment, Baha® BIA300 Implant (diameter 4.5mm; length 4mm) with 6mm abutment, Early loading
- 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® flange fixture (diameter 3.75mm; length 4mm) with 6mm abutmentDevice
The control implant included the previous generation as-machined titanium Baha® flange fixture (diameter 3.75mm; length 4mm) with 6mm conically shaped abutment.
Baha® BIA300 Implant (diameter 4.5mm; length 4mm) with 6mm abutmentDevice
The test implant and the implant used for the 3-week loading trial included the wide diameter titanium implant (diameter 4.5mm; length 4mm) with 6mm rounded, apically converging titanium abutment developed by Cochlear Bone Anchored Solutions AB (Mölnlyncke, Sweden). This system with an additional minor change to the internal abutment connection design was later commercialized under the name Cochlear™ Baha® BIA300 Implant with abutment. In addition to the difference in abutment shape and the wider diameter, the test implant incorporates small-sized threads at the implant neck and the moderately rough TiOblast™ (Dentsply, Mölndal, Sweden) surface on the intraosseous part of the implant6-8.
Early loadingProcedure or surgery
Loading the implant at 3 weeks after implantation (instead of 6 weeks after implantation)
| Study group | Role | What they receive |
|---|---|---|
| Control implant loaded at 6 weeks post-surgery | Active comparator | The control implant included the previous generation as-machined titanium Baha® flange fixture (diameter 3.75mm; length 4mm) with 6mm conically shaped abutment. Receives: Device: Baha® flange fixture (diameter 3.75mm; length 4mm) with 6mm abutment |
| Test implant loaded at 6 weeks post-surgery | Experimental | The test implant and the implant used for the 3-week loading trial included the wide diameter titanium implant (diameter 4.5mm; length 4mm) with 6mm rounded, apically converging titanium abutment developed by Cochlear Bone Anchored Solutions AB (Mölnlyncke, Sweden). This system with an additional minor change to the internal abutment connection design was later commercialized under the name Cochlear™ Baha® BIA300 Implant with abutment. Receives: Device: Baha® BIA300 Implant (diameter 4.5mm; length 4mm) with 6mm abutment |
| Test implant loaded at 3 weeks post-surgery | Experimental | The test implant and the implant used for the 3-week loading trial included the wide diameter titanium implant (diameter 4.5mm; length 4mm) with 6mm rounded, apically converging titanium abutment developed by Cochlear Bone Anchored Solutions AB (Mölnlyncke, Sweden). This system with an additional minor change to the internal abutment connection design was later commercialized under the name Cochlear™ Baha® BIA300 Implant with abutment. Receives: Device: Baha® BIA300 Implant (diameter 4.5mm; length 4mm) with 6mm abutment; Procedure: Early loading |
What is being measured
The primary outcome is the main question the study is designed to answer.
implant stability
Implant Stability Quotiënt (ISQ) will be measured at the 10y-visit. The resonance frequency analysis renders an ISQ value ranging from 1 to 100. Measurements shall be performed at the abutment level, as is done in the previous investigations. The highest and lowest ISQ value out of two perpendicular measurements shall be recorded as ISQ High and ISQ low. The measurement should preferably be done by the same Osstell instrument (Osstell, Gothenburg, Sweden) that was used in the previous completed study. SmartPeg Type 43 and 55 shall be used during the measurement (Osstell, Gothenburg, Sweden). The procedures for obtaining ISQ values is described in the manufacturer's instruction that will be handed out to the investigators.
Measured: 10 years after implantation
Secondary outcomes (3)
implant survival
All patients will be asked if they have experienced any implant osseointegration problems. The time from implantation until implant loss or removal will be noted. In case of implant removal, reason for removal shall be recorded.
Measured: 10 years after implantation
soft tissue reaction
Soft tissue reactions will be measured using the Holgers' classification \& IPS-score.
The Holgers' classification is designed to capture signs and symptoms of inflammation or infection at the site of implantation (scale 0-4).
The IPS-score is a complete standardized assessment scale for skin complications for both percutaneous and transcutaneous implants for bone conduction devices (BCDs) with a proposed treatment advice based on the outcome. The IPS score has three subscales: inflammation (0-4); pain (0-2), and skin height (0-2).
Measured: 10 years after implantation
device use
To evaluate the long-term device use of a Baha®.
Measured: 10 years after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2021
- Study start24 Jun 2019
- Primary completion21 Sep 2020
- Study completion21 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hearing LossStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Cochlear Bone Anchored Solutions
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05058066
- Sponsor's protocol ID
- CAG5173/CBAS5562 10y
- Status last verified
- Sep 2021
- First submitted
- 7 Sep 2021
- Last updated
- 18 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Teunissen EM, Caspers CJI, Vijverberg MA, Mylanus EAM, Hol MKS. Long-Term Follow-up of a Wide-Diameter Bone-Anchored Hearing Implant: 10-Year Experience on Stability, Survival, and Tolerability of an Implant-Abutment Combination. Otol Neurotol. 2023 Jan 1;44(1):40-46. doi: 10.1097/MAO.0000000000003763. Epub 2022 Nov 23.
PubMed 36417764
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Follow-up of a Wide Diameter Bone Anchored Hearing Implant: the 10-year Experience on Stability, Survival and Tolerability of the BIA300®
- ClinicalTrials.gov ID
- NCT05058066
- Acronym / sponsor ID
- CAG5173/CBAS5562 10y
- Conditions
- Hearing Loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Collaborators
- Cochlear Bone Anchored Solutions
- Study start
- 24 Jun 2019 (actual)
- Primary completion
- 21 Sep 2020 (actual)
- Study completion
- 21 Sep 2020 (actual)
- First posted
- 27 Sep 2021 (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.
A single centre, open, comparative, parallel group, prospective clinical investigation with a single 10 year follow up visit.
Detailed description
This study is a continuation of two previous conducted trials:
- Stability, long term survival and tolerability of a novel Baha® implant system, a multi-centre investigation new BIA300 (test) implant vs previous generation (control) implant:
- CAG5173: 6-month(1) and 3-year(2) data.
- CBAS5562: 5-year data(3).
- 3 weeks loading: stability, long term survival and tolerability of a novel Baha® implant system, a multi-centre investigation 3 week loading vs 6+ week loading (= same group as control group trial 1). 6- month(4) and 3-year(5) data.
In this study the (5-year data for trial 2 and) 10-year data regarding stability, survival and soft tissue tolerability from the above mentioned trials will be evaluated and compared. The previous trials were multicentre, but the current study will be single-centred and therefore only include the participants of the Radboud site. Data will be collected at a visit at (5 years, for trial 2 and) 10 years (+/- 6 months) after implantation.
Up to now, no RCT of these implants (with the loading of 3 weeks after implantation) has assessed stability, survival and tolerability over a 10-year follow-up period.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control implant loaded at 6 weeks post-surgery | Active comparator | Device: Baha® flange fixture (diameter 3.75mm; length 4mm) with 6mm abutmentThe control implant included the previous generation as-machined titanium Baha® flange fixture (diameter 3.75mm; length 4mm) with 6mm conically shaped abutment. |
| Test implant loaded at 6 weeks post-surgery | Experimental | Device: Baha® BIA300 Implant (diameter 4.5mm; length 4mm) with 6mm abutmentThe test implant and the implant used for the 3-week loading trial included the wide diameter titanium implant (diameter 4.5mm; length 4mm) with 6mm rounded, apically converging titanium abutment developed by Cochlear Bone Anchored Solutions AB (Mölnlyncke, Sweden). This system with an additional minor change to the internal abutment connection design was later commercialized under the name Cochlear™ Baha® BIA300 Implant with abutment. |
| Test implant loaded at 3 weeks post-surgery | Experimental | Device: Baha® BIA300 Implant (diameter 4.5mm; length 4mm) with 6mm abutment, Procedure: Early loadingThe test implant and the implant used for the 3-week loading trial included the wide diameter titanium implant (diameter 4.5mm; length 4mm) with 6mm rounded, apically converging titanium abutment developed by Cochlear Bone Anchored Solutions AB (Mölnlyncke, Sweden). This system with an additional minor change to the internal abutment connection design was later commercialized under the name Cochlear™ Baha® BIA300 Implant with abutment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- To be included in the original trials, patients had to be at least 18 years old.
Key exclusion criteria (1 listed)
- Exclusion criteria were an inability to follow investigational procedures, any factor at the discretion of the investigator that was considered to contraindicate participation, and any disease or treatment known to compromise the bone quality at the implant site. For patients who had lost or removed the implant, the time to implant loss was recorded. Patients who could not attend the 5 or 10 year follow-up visit for other reasons were included in the implant survival analysis as well; the last available information regarding implant survival was obtained verbally from the patient, from medical records, or from information captured from the original investigations. Furthermore, patients were excluded if they had a bone thickness less than 4 mm at the implant site during implantation.
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® flange fixture (diameter 3.75mm; length 4mm) with 6mm abutmentThe control implant included the previous generation as-machined titanium Baha® flange fixture (diameter 3.75mm; length 4mm) with 6mm conically shaped abutment. | Device | Control implant loaded at 6 weeks post-surgery |
| Baha® BIA300 Implant (diameter 4.5mm; length 4mm) with 6mm abutmentThe test implant and the implant used for the 3-week loading trial included the wide diameter titanium implant (diameter 4.5mm; length 4mm) with 6mm rounded, apically converging titanium abutment developed by Cochlear Bone Anchored Solutions AB (Mölnlyncke, Sweden). This system with an additional minor change to the internal abutment connection design was later commercialized under the name Cochlear™ Baha® BIA300 Implant with abutment. In addition to the difference in abutment shape and the wider diameter, the test implant incorporates small-sized threads at the implant neck and the moderately rough TiOblast™ (Dentsply, Mölndal, Sweden) surface on the intraosseous part of the implant6-8. | Device | Test implant loaded at 3 weeks post-surgery, Test implant loaded at 6 weeks post-surgery |
| Early loadingLoading the implant at 3 weeks after implantation (instead of 6 weeks after implantation) | Procedure or surgery | Test implant loaded at 3 weeks post-surgery |
Primary outcome
implant stability
Time frame: 10 years after implantation
Implant Stability Quotiënt (ISQ) will be measured at the 10y-visit. The resonance frequency analysis renders an ISQ value ranging from 1 to 100. Measurements shall be performed at the abutment level, as is done in the previous investigations. The highest and lowest ISQ value out of two perpendicular measurements shall be recorded as ISQ High and ISQ low. The measurement should preferably be done by the same Osstell instrument (Osstell, Gothenburg, Sweden) that was used in the previous completed study. SmartPeg Type 43 and 55 shall be used during the measurement (Osstell, Gothenburg, Sweden). The procedures for obtaining ISQ values is described in the manufacturer's instruction that will be handed out to the investigators.
3 secondary outcomes
implant survival
Time frame: 10 years after implantation
soft tissue reaction
Time frame: 10 years after implantation
device use
Time frame: 10 years after surgery
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 18 Nov 2025.
- Background: PubMed 36417764Teunissen EM, Caspers CJI, Vijverberg MA, Mylanus EAM, Hol MKS. Long-Term Follow-up of a Wide-Diameter Bone-Anchored Hearing Implant: 10-Year Experience on Stability, Survival, and Tolerability of an Implant-Abutment Combination. Otol Neurotol. 2023 Jan 1;44(1):40-46. doi: 10.1097/MAO.0000000000003763. Epub 2022 Nov 23.
- Individual participant dataSharing planned: Undecided
Related trials for Hearing Loss
RecruitingObservational study
Impact of Vestibular Function on Deaf Infants' Activities of Daily Living
Vestibular Dysfunction, Hearing Loss
Recruiting
HEARS-NPS: Addressing Hearing Loss as a Common Unmet Contributor of Neuropsychiatric Symptoms
Alzheimer Disease, Dementia
Not yet recruiting
Hearing Intervention Effects on Brain and Language Development in Children With Bilateral Mild Hearing Loss
Hearing Loss, Bilateral
RecruitingObservational study
Natural History of Autosomal Dominant Hearing Loss
Hearing Loss
RecruitingObservational study
Retrospective Analysis of Speech Performance Using the HiRes Ultra and HiRes Ultra 3D Cochlear Implant
Cochlear Hearing Loss
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Baha® flange fixture (diameter 3.75mm; length 4mm) with 6mm abutment, Baha® BIA300 Implant (diameter 4.5mm; length 4mm) with 6mm abutment and Early loading in people with Hearing Loss, run by Radboud University Medical Center at 1 site in Netherlands.
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 1 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 18 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. 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?
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?
implant stability (time frame: 10 years after implantation). 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 NCT05058066, which also lists 1 linked publication.
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 18 Nov 2025.