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.

Study Overview

• Status: Recruiting
• Conditions: Hearing Loss; Bone Anchored Hearing Aids
• Intervention / Treatment: Device: Ponto implantation

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 Type: Observational
• Enrollment (Estimated): 270

Contacts and Locations

• Study Contact: Name: Sara Al-Dalal; Phone Number: +46 70-149 25 03; Email: srld@oticonmedical.com
• Study Contact Backup: Name: Sara Svensson; Phone Number: +46735042041; Email: ssve@oticonmedical.com

Study Locations

• Sweden
  • Norrbotten
    • Luleå, Norrbotten, Sweden, 971 80
      • Recruiting
      • Sunderby Sjukhus
      • Contact: Dr Rönnblom; Phone Number: +46 703 773 666; Email: anton.ronnblom@norrbotten.se
      • Principal Investigator: Anton Rönnblom
  • Skåne
    • Lund, Skåne, Sweden, 22185
      • Recruiting
      • Skåne University Hospital
      • Contact: Dr Gisselsson-Solén; Phone Number: +46 46-172815; Email: Marie.Gisselsson-Solen@skane.se
      • Principal Investigator: Marie Gisselsson-Solén

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Bone-conduction hearing device users

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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	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.
Prospective group; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Intraoperative complications at surgery	During the Ponto-implantation surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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'	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.	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)	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.	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.	3 months after surgery, and through study completion, an average of 1 year.
To assess time from surgery to sound processor loading		Time from surgery to sound processor loading which happens at an average of 3 months after surgery.
To assess sound processor usage time		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.	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.	3 months after surgery

Collaborators and Investigators

• Sponsor: Oticon Medical
• Investigators: Principal Investigator: Dr David Morris, Queen Elizabeth II Health Sciences Centre

Study record dates

Study Major Dates

• Study Start (Actual): May 7, 2025
• Primary Completion (Estimated): October 30, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: April 1, 2025
• First Submitted That Met QC Criteria: April 8, 2025
• First Posted (Actual): April 16, 2025

Study Record Updates

• Last Update Posted (Actual): May 18, 2025
• Last Update Submitted That Met QC Criteria: May 16, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Ear Diseases; Hearing Disorders; Hearing Loss
• Other Study ID Numbers: BC118; CIV-ID 25-01-051014 (Other Identifier: Swedish Medical Products Agency)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No