Recruiting

Ponto-Implantations

Sponsor:

Oticon Medical

Code:

NCT06930781

Conditions

Hearing Loss

Bone Anchored Hearing Aids

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Ponto implantation

Study Details

Brief 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.

Conditions

Hearing Loss

Bone Anchored Hearing Aids

Study ID

NCT06930781

Start date

May 7, 2025

Status verified date

Jul, 2026

Completion date

Apr 1, 2027

Anticipated

Primary completion date

Mar 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

270 participants

Anticipated

Interventions and Outcome Measures

Arms

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

Prospective group

Patients who have undergone Ponto implantation in an out-of-OR setting and participated in the study by filling out questionnaires.

Interventions

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.

Primary outcome measure

  • Intraoperative complications at surgery [ Time Frame: During the Ponto-implantation surgery ]

Central Contacts and Locations

Central contacts

Sara Al-Dalal

+46 70-149 25 03srld@oticonmedical.com

Sara Svensson

+46735042041ssve@oticonmedical.com

Locations

Northern California Veterans Affairs Healthcare System

Recruiting

Sacramento, California, United States, 95655

Contacts

Dr Lane Squires

916-734-5400lane.squires@va.gov

Queen Elizabeth II Health Sciences Centre

Recruiting

Halifax, Nova Scotia, Canada, B3H 2Y9

Contacts

Dr David Morris

902-473-1986DPMorrisENT@nshealth.ca

More Information

Sponsor

Oticon Medical

Last update posted

Jul 8, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Oticon Medical on 2026-07-08.