Hearing LossNCT06930781
Evaluation of Clinical Outcomes of Ponto Procedures Performed in Settings Outside the Main Operating Room (i.e. Out-of-OR)
An observational study of Hearing Loss and Bone Anchored Hearing Aids, run by Oticon Medical at 6 sites in 5 countries.
Trial summary
This study is a combined retro- and prospective, single arm, multicentre investigation designed to follow clinical practice for Ponto-implantations performed out of OR. The overall objective is to investigate the complication rate for procedures performed out-of-OR. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hearing Loss, Bone Anchored Hearing Aids
- What is being tested?
- Ponto implantation
- Type of treatment
- Medical device
- How many people
- 270 participants
- Where
- 6 sitesin 5 countries
- Study dates
- 7 May 2025to 1 Apr 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: Bone-conduction hearing device users
Who may be able to join
- Adult subjects (≥18 years old) undergoing Ponto implantation in an out-of-OR setting from 2019 and onwards
- Signed informed consent (applicable for subjects answering questionnaires)
Who cannot join
- No exclusion criteria have been set for this observational investigation
Trial locations and contacts
6 sites in 5 countries. Contact the study team or a site near you to ask about taking part.
6 sites in 5 countries
Sweden2 sites
- Active, not recruiting
Sunderby Sjukhus
Luleå, Norrbotten County, 971 80
- Active, not recruiting
Skåne University Hospital
Lund, Skåne County, 22185
United States1 site, 1 recruiting
- Recruiting
Northern California Veterans Affairs Healthcare System
Sacramento, California, 95655
Dr Lane Squires, 916-734-5400, lane.squires@va.gov
Brazil1 site
- Active, not recruiting
Clinical Hospital from the Ribeirão Preto Medical School
São Paulo, São Paulo, 3900
Canada1 site, 1 recruiting
- Recruiting
Queen Elizabeth II Health Sciences Centre
Halifax, Nova Scotia, B3H 2Y9
Dr David Morris, 902-473-1986, DPMorrisENT@nshealth.ca
Spain1 site
- Active, not recruiting
Hospital Virgen de las Nieves
Granada, Andalusia, 18014
About this study
This study is a combined retro- and prospective, single arm, multicentre investigation designed to follow clinical practice for Ponto-implantations performed out of OR. The overall objective is to investigate the complication rate for procedures performed out-of-OR.
Read the detailed description
The study is observational and non interventional and follows clinical practice at participating clinics with the only exception of three questionnaires given to consenting patients after surgery and during follow-up, after loading of the sound processor.
The study is a combined retro- and prospective study. The retrospective part consists of a chart review of patients who have undergone Ponto-implantation out of OR from 2019 and onwards. The prospectively recruited subjects are patients who are planned to undergo Ponto-implantation surgery out-of-OR.
- Conditions
- Hearing Loss, Bone Anchored Hearing Aids
- Being tested
- Ponto implantation
- Medical subject headings
- Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ponto implantationDevice
Ponto implantation is a surgical procedure to implant a bone-anchored hearing device, improving hearing by transmitting sound directly to the inner ear through bone conduction.
| Study group | Role | What they receive |
|---|---|---|
| Retrospective group | Data gathered from retrospective chart reviews of patients who have undergone Ponto-implantation in an out-of-OR setting from 2019 and onwards Receives: Device: Ponto implantation | |
| Prospective group | Patients who have undergone Ponto implantation in an out-of-OR setting and participated in the study by filling out questionnaires. Receives: Device: Ponto implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraoperative complications at surgery
Measured: During the Ponto-implantation surgery
Secondary outcomes (9)
Assessment of procedure room variables
To make an assessment of how procedure rooms that are used for Ponto out-of-OR surgeries look like. Will be measured using the 'Procedure room used for Out-of-OR Ponto-surgery questionnaire'
Measured: 12 months after study start
To assess surgical parameters
With this outcome, the aim is to assess the surgical variables present during Ponto out-of-OR surgeries. A series of yes or no questions will be presented in a form to the surgeon regarding the use of anesthesia, sedatives, implants, and abutments of different lengths. The results will be presented in a table.
Measured: During Ponto-implantation surgery
Evaluation of patient experience of surgical procedure based on Ponto procedure questionnaire
Score is reported on a scale of 5 steps, were the lowest value (1) is the worst and the highest value is the best (5)
Measured: 5-10 days after Ponto surgery
To assess postoperative events and complications
All postoperative events and complications will be presented in a descriptive table, listing how many were affected by each type of event or complication.
Measured: From day of surgery, through study completion, an average of 1 year
To assess rate of implant survival
Implant survival will be assessed at least once, at 3 months. If follow-up data is available, implant survival will be assessed through study completion, an average of 1 year.
Measured: 3 months after surgery, and through study completion, an average of 1 year.
To assess time from surgery to sound processor loading
Measured: Time from surgery to sound processor loading which happens at an average of 3 months after surgery.
To assess sound processor usage time
Measured: 3 months after surgery, and through study completion, an average of 1 year.
To assess effectiveness of hearing rehabilitation using IOI-HA questionnaire
Will be assessed using the standardised questionnaire International Outcome Inventory for Hearing Aids (IOI-HA) score at 3 months post-surgery. In the questionnaire, each item has five response choices proceeding from the worst outcome to the best outcome (1-5). The score will be presented as mean score with, standard deviation and median for the two groups.
Measured: 3 months after surgery
To assess patient-reported benefit after BAHS treatment using the questionnaire Glasgow Benefit Inventory (GBI)
Glasgow Benefit Inventory (GBI) benefit scores will be presented for total-, general-, social- and physical scores at 3 months post-surgery. The GBI uses a scale from -100 to +100, where scores above 0 indicate improved quality of life.
Measured: 3 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2025
- Study start7 May 2025
- Primary completion30 Mar 2027 (estimated)
- Study completion1 Apr 2027 (estimated)
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
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 270 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oticon Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dr David Morris, Principal investigator, Queen Elizabeth II Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06930781
- Sponsor's protocol ID
- BC118
- Other IDs
- CIV-ID 25-01-051014
- Status last verified
- Jul 2026
- First submitted
- 1 Apr 2025
- Last updated
- 8 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Clinical Outcomes of Ponto Procedures Performed in Settings Outside the Main Operating Room (i.e. Out-of-OR)
- ClinicalTrials.gov ID
- NCT06930781
- Acronym / sponsor ID
- BC118
- Conditions
- Hearing Loss, Bone Anchored Hearing Aids
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 270 participants (estimated)
- Lead sponsor
- Oticon MedicalIndustry (pharma, biotech, devices)
- Study start
- 7 May 2025 (actual)
- Primary completion
- 30 Mar 2027 (estimated)
- Study completion
- 1 Apr 2027 (estimated)
- First posted
- 16 Apr 2025 (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.
This study is a combined retro- and prospective, single arm, multicentre investigation designed to follow clinical practice for Ponto-implantations performed out of OR. The overall objective is to investigate the complication rate for procedures performed out-of-OR.
Detailed description
The study is observational and non interventional and follows clinical practice at participating clinics with the only exception of three questionnaires given to consenting patients after surgery and during follow-up, after loading of the sound processor.
The study is a combined retro- and prospective study. The retrospective part consists of a chart review of patients who have undergone Ponto-implantation out of OR from 2019 and onwards. The prospectively recruited subjects are patients who are planned to undergo Ponto-implantation surgery out-of-OR.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Retrospective group | – | Device: Ponto implantationData gathered from retrospective chart reviews of patients who have undergone Ponto-implantation in an out-of-OR setting from 2019 and onwards |
| Prospective group | – | Device: Ponto implantationPatients who have undergone Ponto implantation in an out-of-OR setting and participated in the study by filling out questionnaires. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Bone-conduction hearing device users
Key inclusion criteria (2 listed)
- Adult subjects (≥18 years old) undergoing Ponto implantation in an out-of-OR setting from 2019 and onwards
- Signed informed consent (applicable for subjects answering questionnaires)
Key exclusion criteria (1 listed)
- No exclusion criteria have been set for this observational investigation
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 |
|---|---|---|
| Ponto implantationPonto implantation is a surgical procedure to implant a bone-anchored hearing device, improving hearing by transmitting sound directly to the inner ear through bone conduction. | Device | Prospective group, Retrospective group |
Primary outcome
Intraoperative complications at surgery
Time frame: During the Ponto-implantation surgery
9 secondary outcomes
Assessment of procedure room variables
Time frame: 12 months after study start
To assess surgical parameters
Time frame: During Ponto-implantation surgery
Evaluation of patient experience of surgical procedure based on Ponto procedure questionnaire
Time frame: 5-10 days after Ponto surgery
To assess postoperative events and complications
Time frame: From day of surgery, through study completion, an average of 1 year
To assess rate of implant survival
Time frame: 3 months after surgery, and through study completion, an average of 1 year.
To assess time from surgery to sound processor loading
Time frame: Time from surgery to sound processor loading which happens at an average of 3 months after surgery.
To assess sound processor usage time
Time frame: 3 months after surgery, and through study completion, an average of 1 year.
To assess effectiveness of hearing rehabilitation using IOI-HA questionnaire
Time frame: 3 months after surgery
To assess patient-reported benefit after BAHS treatment using the questionnaire Glasgow Benefit Inventory (GBI)
Time frame: 3 months after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2026.
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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.
Dr David Morris principal investigator
Queen Elizabeth II Health Sciences Centre
6 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hearing Loss and Bone Anchored Hearing Aids, run by Oticon Medical at 6 sites in 5 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 2 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: looking for participants now, as of the sponsor's last update on 8 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Sweden, United States, Brazil, Canada, Spain. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sara Al-Dalal (+46 70-149 25 03, srld@oticonmedical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intraoperative complications at surgery (time frame: During the Ponto-implantation surgery). 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 8 Jul 2026.