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Complication rates of Ponto hearing implant surgery done outside the main operating room

Looks at complications of Ponto hearing implants placed outside the operating room, in adults.

Key facts

Who runs it
Oticon Medical
Where
Sacramento, United StatesSee the siteAlso in 4 other countries, 5 sites
Trial code
Registry title
Evaluation of Clinical Outcomes of Ponto Procedures Performed in Settings Outside the Main Operating Room (i.e. Out-of-OR)
Status
Recruiting
People taking part
270 people, planned
Started
7 May 2025
Expected to end
1 Apr 2027
Type of study
Observational, 2 groups
Treatments tested
  • Ponto implantation
Record updated
8 July 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults who had a Ponto implant (a bone-anchored hearing aid) placed outside the main operating room from 2019 onwards. It studies how often problems happen after these procedures.

Age
18 years and older
Sex
All sexes
Disease stage
Hearing loss treated with a Ponto bone-anchored hearing aid
Earlier treatment
Must be having or have had Ponto implantation outside the main operating room, from 2019 onwards

The registry criteria, word for word

Show all 3 criteriaShow less

Who can take part

  • 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)

Who cannot take part

  • No exclusion criteria have been set for this observational investigation

Where in United States

Also in 4 other countries, 5 sites

  • Northern California Veterans Affairs Healthcare SystemSacramento, United StatesContact: Dr Lane SquiresTaking people

About the trial

What the trial wants to find out

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.

The 2 groups in the trial

  • 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

    Treatment: Ponto implantation

  • Prospective group

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

    Treatment: Ponto implantation

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Evaluation of Clinical Outcomes of Ponto Procedures Performed in Settings Outside the Main Operating Room (i.e. Out-of-OR)
Plain-language title
Complication rates of Ponto hearing implant surgery done outside the main operating roomGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 14 November 2026.
Record updated
8 July 2026