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

NCT ID: NCT05356221

Last Updated: 2025-08-17

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

170 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-04-11

Study Completion Date

2024-09-01

Brief Summary

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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

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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.

Conditions

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Hearing Loss Hearing Loss, Conductive Hearing Loss, Unilateral

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Ponto Users

Users that have been fitted with a Bone Anhcored Sound Processor, Ponto

Ponto Sound processor

Intervention Type DEVICE

Bone Anchored Hearing solution fitted to compensate for the subjects hearing loss

Interventions

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Ponto Sound processor

Bone Anchored Hearing solution fitted to compensate for the subjects hearing loss

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Oticon Medical

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Marianne Philipsson

Role: STUDY_DIRECTOR

Oticon Medical

Locations

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Oticon Medical

Somerset, New Jersey, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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BC112

Identifier Type: -

Identifier Source: org_study_id

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