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

BC112 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.

Study Overview

• Status: Completed
• Conditions: Hearing Loss; Hearing Loss, Conductive; Hearing Loss, Unilateral
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 170

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Somerset, New Jersey, United States, 08873
      • Oticon Medical

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Users fitted with a Ponto sound processor

Description

Inclusion Criteria:

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

Exclusion Criteria:

No exclusion criteria

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall IOI-HA Score	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.	at enrollment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Upgrade	Evaluate Ponto sound processor upgrade rate	enrollment
Factor 1 IOI-HA Score	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	at enrollement
Factor 2 IOI-HA Score	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	at enrollment
Per Item IOI-HA Score (Q1)	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	at enrollment
Per Item IOI-HA Score (Q2)	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	at enrollment
Per Item IOI-HA Score (Q3)	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	at enrollment
Per Item IOI-HA Score (Q4)	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	at enrollment
Per Item IOI-HA Score (Q5)	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	at enrollment
Per Item IOI-HA Score (Q6)	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	at enrollment
Per Item IOI-HA Score (Q7)	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	at enrollment
Usage	Evaluate non-usage among patients fitted with a Ponto sound processor. Reported is number of participants by sound processor type.	at enrollment

Collaborators and Investigators

• Sponsor: Oticon Medical
• Investigators: Study Director: Marianne Philipsson, Oticon Medical

Study record dates

Study Major Dates

• Study Start (Actual): April 11, 2022
• Primary Completion (Actual): September 1, 2024
• Study Completion (Actual): September 1, 2024

Study Registration Dates

• First Submitted: April 26, 2022
• First Submitted That Met QC Criteria: April 26, 2022
• First Posted (Actual): May 2, 2022

Study Record Updates

• Last Update Posted (Actual): August 17, 2025
• Last Update Submitted That Met QC Criteria: July 30, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Ear Diseases; Hearing Disorders; Hearing Loss; Deafness; Hearing Loss, Conductive; Hearing Loss, Unilateral
• Other Study ID Numbers: BC112

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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