Cross-sectional Evaluation of the Subjective Performance and Satisfaction With Ponto Sound Processors (BC112)

May 10, 2022 updated by: Oticon Medical

BC112 Cross-sectional Evaluation of the Subjective Performance and Satisfaction With Ponto Sound Processors

The study is a non-interventional, observational, cross-sectional, study on users of Ponto sound processors. The purpose of this study is to evaluate subjectively assessed hearing performance and satisfaction with Oticon Medical's sound processors fitted with the Genie Medical fitting software.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The study is a non-interventional, observational, cross-sectional, study on users of Ponto sound processors. The purpose of this study is to evaluate subjectively assessed hearing performance and satisfaction with Oticon Medical's sound processors fitted with the Genie Medical fitting software. Subjects fitted with one or two Ponto sound processors will be invited to participate in an online survey. The survey contains questions about the subjectively experienced performance and satisfaction of the device. The survey can be filled out on computer, tablet or mobile phone and should take the participants about 10 minutes to fill out.

Study Type

Observational

Enrollment (Anticipated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • New Jersey
      • Somerset, New Jersey, United States, 08873
        • Recruiting
        • Oticon Medical
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Users fitted with a Ponto sound processor

Description

Inclusion Criteria:

Online consent form filled out Has been fitted with at least one Ponto Sound Processor

Exclusion Criteria:

No exclusion criteria

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Ponto Users
Users that have been fitted with a Bone Anhcored Sound Processor, Ponto
Device: Ponto Sound processor
Bone Anchored Hearing solution fitted to compensate for the subjects hearing loss

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall IOI-HA score
Time Frame: at enrollment
International Outcome Inventory for Hearing Aids score. 5 item categorical scale ranging from worst outcome to best outcome. Evaluate subjectively assessed overall hearing performance and satisfaction with the Oticon Medical's Ponto sound processors.
at enrollment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Factor 1 IOI-HA score
Time Frame: at enrollement
Factor 1 International Outcome Inventory for Hearing Aids score. 5 item categorical scale ranging from worst outcome to best outcome. Evaluate the subjectively assessed performance and satisfaction with Oticon Medical's Ponto sound processors
at enrollement
Factor 2 IOI-HA score
Time Frame: at enrollment
Factor 2 International Outcome Inventory for Hearing Aids score. 5 item categorical scale ranging from worst outcome to best outcome. Evaluate the subjectively assessed performance and satisfaction with Oticon Medical's Ponto sound processors
at enrollment
Per item IOI-HA score
Time Frame: at enrollment
Per item International Outcome Inventory for Hearing Aids score. 5 item categorical scale ranging from worst outcome to best outcome. Evaluate the subjectively assessed performance and satisfaction with Oticon Medical's Ponto sound processors
at enrollment
Usage
Time Frame: at enrollment
Evaluate non-usage among patients fitted with a Ponto sound processor
at enrollment
Upgrade
Time Frame: enrollment
Evaluate Ponto sound processor upgrade rate
enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oticon Medical

Investigators

  • Study Director: Marianne Philipsson, Oticon Medical

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 11, 2022

Primary Completion (ANTICIPATED)

April 30, 2023

Study Completion (ANTICIPATED)

April 30, 2023

Study Registration Dates

First Submitted

April 26, 2022

First Submitted That Met QC Criteria

April 26, 2022

First Posted (ACTUAL)

May 2, 2022

Study Record Updates

Last Update Posted (ACTUAL)

May 17, 2022

Last Update Submitted That Met QC Criteria

May 10, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BC112

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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