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NCT Number: NCT06930781

Evaluation of Clinical Outcomes of Ponto Procedures Performed in Settings Outside the Main Operating Room (i.e. Out-of-OR)

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Clinical Hospital from the Ribeirão Preto Medical School, São Paulo, Brazil

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)

Exclusion criteria

  • No exclusion criteria have been set for this observational investigation

Treatment and study plan

Ponto implantation

Device

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.

Primary outcomes

  1. Intraoperative complications at surgery

    Time frame: During the Ponto-implantation surgery

Secondary outcomes

  1. Assessment of procedure room variables

    Time frame: 12 months after study start

    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'

  2. To assess surgical parameters

    Time frame: During Ponto-implantation surgery

    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.

  3. Evaluation of patient experience of surgical procedure based on Ponto procedure questionnaire

    Time frame: 5-10 days after Ponto surgery

    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)

  4. To assess postoperative events and complications

    Time frame: From day of surgery, through study completion, an average of 1 year

    All postoperative events and complications will be presented in a descriptive table, listing how many were affected by each type of event or complication.

  5. To assess rate of implant survival

    Time frame: 3 months after surgery, and through study completion, an average of 1 year.

    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.

  6. 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.

  7. To assess sound processor usage time

    Time frame: 3 months after surgery, and through study completion, an average of 1 year.

  8. To assess effectiveness of hearing rehabilitation using IOI-HA questionnaire

    Time frame: 3 months after surgery

    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.

  9. To assess patient-reported benefit after BAHS treatment using the questionnaire Glasgow Benefit Inventory (GBI)

    Time frame: 3 months after surgery

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Sara Al-Dalal

CONTACT

[email protected]

+46 70-149 25 03

Sara Svensson

CONTACT

[email protected]

+46735042041

Sponsors and collaborators

Lead sponsor

Oticon Medical

Industry

Registry information

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Apr 16, 2025
Registry last updated
Jul 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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