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Completed

NCT Number: NCT05356221

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.

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Key information

Conditions

Hearing Loss Ear Diseases Hearing Disorders Hearing Loss, Conductive Hearing Loss, Unilateral Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Oticon Medical

Somerset, New Jersey, 08873, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

No exclusion criteria

Treatment and study plan

Ponto Sound processor

Device

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

Primary outcomes

  1. Overall IOI-HA Score

    Time frame: at enrollment

    International Outcome Inventory for Hearing Aids score. 5 item categorical scale ranging from worst outcome (1) to best outcome (5). Evaluate subjectively assessed overall hearing performance and satisfaction with the Oticon Medical's Ponto sound processors.

Secondary outcomes

  1. 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 (1) to best outcome (5). Evaluate the subjectively assessed performance and satisfaction with Oticon Medical's Ponto sound processors

  2. 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 (1) to best outcome (5). Evaluate the subjectively assessed performance and satisfaction with Oticon Medical's Ponto sound processors

  3. Per Item IOI-HA Score (Q1)

    Time frame: at enrollment

    Per item International Outcome Inventory for Hearing Aids score. 5 item categorical scale ranging from worst outcome (1) to best outcome (5). Here, this item queries average hours of use per day and a score of 1 is assigned for "none", a score of 2 assigned for "less than one hour per day", a score of 3 assigned for "1 to 4 hours per day", a score of 4 for "4 to 8 hours a day", and a score of 5 assigned for "more than 8 hours a day". Evaluate the subjectively assessed performance and satisfaction with Oticon Medical's Ponto sound processors

  4. Per Item IOI-HA Score (Q2)

    Time frame: at enrollment

    Per item International Outcome Inventory for Hearing Aids score. 5 item categorical scale ranging from worst outcome (1: helped not at all) to best outcome (5: helped very much). Evaluate the subjectively assessed performance and satisfaction with Oticon Medical's Ponto sound processors

  5. Per Item IOI-HA Score (Q3)

    Time frame: at enrollment

    Per item International Outcome Inventory for Hearing Aids score. 5 item categorical scale ranging from worst outcome (1: Very much difficulty) to best outcome (5: No difficulty). Evaluate the subjectively assessed performance and satisfaction with Oticon Medical's Ponto sound processors

  6. Per Item IOI-HA Score (Q4)

    Time frame: at enrollment

    Per item International Outcome Inventory for Hearing Aids score. 5 item categorical scale ranging from worst outcome (1: Not worth it at all) to best outcome (5: Very much worth it). Evaluate the subjectively assessed performance and satisfaction with Oticon Medical's Ponto sound processors

  7. Per Item IOI-HA Score (Q5)

    Time frame: at enrollment

    Per item International Outcome Inventory for Hearing Aids score. 5 item categorical scale ranging from worst outcome (1: Affected very much) to best outcome (5: Affected not at all). Evaluate the subjectively assessed performance and satisfaction with Oticon Medical's Ponto sound processors

  8. Per Item IOI-HA Score (Q6)

    Time frame: at enrollment

    Per item International Outcome Inventory for Hearing Aids score. 5 item categorical scale ranging from worst outcome (1: bothered very much) to best outcome (5: Bothered not at all). Evaluate the subjectively assessed performance and satisfaction with Oticon Medical's Ponto sound processors

  9. Per Item IOI-HA Score (Q7)

    Time frame: at enrollment

    Per item International Outcome Inventory for Hearing Aids score. 5 item categorical scale ranging from worst outcome (1: Worse) to best outcome (5: Very much better). Evaluate the subjectively assessed performance and satisfaction with Oticon Medical's Ponto sound processors

  10. Usage

    Time frame: at enrollment

    Evaluate non-usage among patients fitted with a Ponto sound processor. Reported is number of participants by sound processor type.

  11. Upgrade

    Time frame: enrollment

    Evaluate Ponto sound processor upgrade rate

Sponsors and collaborators

Lead sponsor

Oticon Medical

Industry

Registry information

Official study title

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

Acronym: BC112

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
May 2, 2022
Registry last updated
Aug 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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