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NCT05356221 Clinical Trial

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

Hearing Loss Clinical Trial

— BC112  

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05356221
Other study ID # BC112
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date April 11, 2022
Est. completion date April 30, 2023

Study information
Verified date April 2022
Source Oticon Medical
Contact Marianne Philipsson
Phone 0046 (0) 702777332
Email maph@oticonmedical.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 1000
Est. completion date April 30, 2023
Est. primary completion date April 30, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: Online consent form filled out Has been fitted with at least one Ponto Sound Processor Exclusion Criteria: No exclusion criteria

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Ponto Sound processor
Bone Anchored Hearing solution fitted to compensate for the subjects hearing loss

Locations
Country Name City State
United States Oticon Medical Somerset New Jersey

Sponsors (1)
Lead Sponsor Collaborator
Oticon Medical

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Overall IOI-HA score 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 Factor 1 IOI-HA score 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
Secondary Factor 2 IOI-HA score 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
Secondary Per item IOI-HA score 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
Secondary Usage Evaluate non-usage among patients fitted with a Ponto sound processor at enrollment
Secondary Upgrade Evaluate Ponto sound processor upgrade rate enrollment
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