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

Purpose

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

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Phase
Study Type
Observational
Observational Model
Other
Time Perspective
Other

Arm Groups

ArmDescriptionAssigned Intervention
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.

Recruiting Locations

Northern California Veterans Affairs Healthcare System
Sacramento, California 95655
Contact:
Dr Lane Squires
916-734-5400
lane.squires@va.gov

More Details

Status
Recruiting
Sponsor
Oticon Medical

Study Contact

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

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.