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

• Conditions: Hearing Loss, Conductive; Hearing Loss; Hearing Loss, Unilateral
• Interventions: Device: Ponto Sound processor

• Registration Number: NCT05356221
• Lead Sponsor: Oticon Medical

Brief 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.

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 Timeline

• Status Verified: 2022-04
• Study Start: 2022-04-11
• Study First Submitted: 2022-04-26
• Study First Submitted QC: 2022-04-26
• Study First Posted: 2022-05-02
• Last Update Submitted: 2022-05-10
• Last Update Posted: 2022-05-17
• Primary Completion: 2023-04-30
• Study Completion: 2023-04-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

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

Exclusion Criteria

No exclusion criteria

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Ponto Users	Ponto Sound processor	Users that have been fitted with a Bone Anhcored Sound Processor, Ponto

Primary Outcome Measures

Name	Time	Method
Overall IOI-HA score	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.

Secondary Outcome Measures

Name	Time	Method
Factor 1 IOI-HA score	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
Usage	at enrollment	Evaluate non-usage among patients fitted with a Ponto sound processor
Per item IOI-HA score	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
Upgrade	enrollment	Evaluate Ponto sound processor upgrade rate
Factor 2 IOI-HA score	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

Trial Locations

Locations (1)

Oticon Medical; 🇺🇸 Somerset, New Jersey, United States