An observational study in Hearing Loss and Bone Anchored Hearing Aids, sponsored by Oticon Medical. Recruiting at 6 sites in 5 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-08.
Sponsored by Oticon Medical · Observational
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.
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.
796 studies on the registry are indexed under Hearing Loss; 193 are open to participants now.
This study's planned enrollment of 270 is above the median of 100 across 192 observational studies indexed under Hearing Loss.
Browse Hearing Loss studies →Oticon Medical is the lead sponsor of 45 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Bone-conduction hearing device users
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Data gathered from retrospective chart reviews of patients who have undergone Ponto-implantation in an out-of-OR setting from 2019 and onwards
Device: Ponto implantation
Patients who have undergone Ponto implantation in an out-of-OR setting and participated in the study by filling out questionnaires.
Device: Ponto implantation
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.
Intraoperative complications at surgery
Time frame: During the Ponto-implantation surgery
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'
Time frame: 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.
Time frame: 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)
Time frame: 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.
Time frame: 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.
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
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.
Time frame: 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.
Time frame: 3 months after surgery
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Started May 2025 (actual). Primary completion is estimated for Mar 2027, 22 months after the start.
Of 98 observational studies under Hearing Loss, half reached primary completion within 42 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 83. This study's planned 22 months is below that.
How these figures are worked out, and which studies are left out of them.
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