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

Who can join

Ages 18 and older · All sexes

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

About the 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.

What is being tested

• Ponto implantation (device)

Sponsor: Oticon Medical · Participants: 270 · Started: May 7, 2025

Contact the study team

• Sara Al-Dalal · Phone: +46 70-149 25 03
• Sara Svensson · Phone: +46735042041

Official record on ClinicalTrials.gov — NCT06930781

Locations in the U.S.

Conditions

• Hearing Loss

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.