N/A
Completed N=170
Cross-sectional Evaluation of the Subjective Performance and Satisfaction With Ponto Sound Processors
Hearing Loss · Hearing Loss, Conductive · Hearing Loss, Unilateral
Source: ClinicalTrials.gov NCT05356221 ↗
Enrolled (actual)
170
Serious AEs
—
Results posted
Aug 2025
Primary outcomePrimary: Overall IOI-HA Score — 3.98; 3.96; 3.86; 4.02 score on a scale
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall IOI-HA Score |
3.98; 3.96; 3.86; 4.02; 4.22; 4.11 | — |
| SECONDARY Factor 1 IOI-HA Score |
4.2; 4.2; 4.1; 4.3; 4.6; 4.3 | — |
| SECONDARY Factor 2 IOI-HA Score |
3.7; 3.7; 3.5; 3.7; 3.8; 3.7 | — |
| SECONDARY Per Item IOI-HA Score (Q1) |
1; 0; 0; 0; 0; 0 | — |
| SECONDARY Per Item IOI-HA Score (Q2) |
2; 0; 0; 0; 0; 0 | — |
| SECONDARY Per Item IOI-HA Score (Q3) |
1; 1; 1; 3; 0; 1 | — |
| SECONDARY Per Item IOI-HA Score (Q4) |
1; 1; 0; 0; 0; 0 | — |
| SECONDARY Per Item IOI-HA Score (Q5) |
2; 0; 1; 3; 0; 2 | — |
| SECONDARY Per Item IOI-HA Score (Q6) |
1; 0; 2; 1; 0; 0 | — |
| SECONDARY Per Item IOI-HA Score (Q7) |
0; 1; 0; 0; 0; 0 | — |
| SECONDARY Usage |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Upgrade |
16; 11; 12; 23; 5; 12 | — |
Eligibility Criteria
Inclusion Criteria
Online consent form filled out Has been fitted with at least one Ponto Sound Processor
Exclusion Criteria
No exclusion criteria
Data sourced from ClinicalTrials.gov (NCT05356221). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.