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

Sponsor
Oticon Medical (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05356221
Collaborator
(none)
1,000
Enrollment
1
Location
12.6
Anticipated Duration (Months)
79.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Ponto Sound processor

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 Design

Study Type:
Observational
Anticipated Enrollment :
1000 participants
Observational Model:
Case-Only
Time Perspective:
Cross-Sectional
Official Title:
BC112 Cross-sectional Evaluation of the Subjective Performance and Satisfaction With Ponto Sound Processors
Actual Study Start Date :
Apr 11, 2022
Anticipated Primary Completion Date :
Apr 30, 2023
Anticipated Study Completion Date :
Apr 30, 2023

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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

  2. 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

  3. 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

  4. Usage [at enrollment]

    Evaluate non-usage among patients fitted with a Ponto sound processor

  5. Upgrade [enrollment]

    Evaluate Ponto sound processor upgrade rate

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

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

Exclusion Criteria:

No exclusion criteria

Contacts and Locations

Locations

Site City State Country Postal Code
1 Oticon Medical Somerset New Jersey United States 08873

Sponsors and Collaborators

  • Oticon Medical

Investigators

  • Study Director: Marianne Philipsson, Oticon Medical

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Oticon Medical
ClinicalTrials.gov Identifier:
NCT05356221
Other Study ID Numbers:
  • BC112
First Posted:
May 2, 2022
Last Update Posted:
May 17, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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
Additional relevant MeSH terms:
Hearing Loss
Deafness
Hearing Loss, Conductive
Hearing Loss, Unilateral

Study Results

No Results Posted as of May 17, 2022