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

Recruiting now

Conditions studied: Hearing Loss, Bone Anchored Hearing Aids

In brief

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.

Key facts

Study ID

NCT06930781

Run by

Oticon Medical

People needed

270

Starts

2025-05-07

Expected to finish

2027-04-01

Last updated by the study team

2026-07-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• No exclusion criteria have been set for this observational investigation

Where it is running

• Northern California Veterans Affairs Healthcare System — Sacramento, California, United States (enrolling)
• Queen Elizabeth II Health Sciences Centre — Halifax, Nova Scotia, Canada (enrolling)
• Clinical Hospital from the Ribeirão Preto Medical School — São Paulo, São Paulo, Brazil
• Hospital Virgen de las Nieves — Granada, Andalusia, Spain
• Sunderby Sjukhus — Luleå, Norrbotten County, Sweden
• Skåne University Hospital — Lund, Skåne County, Sweden

Full record on ClinicalTrials.gov

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