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

Study Overview
=================
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.

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.

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

Conditions
-----------------
Hearing Loss, Hearing Loss, Conductive, Hearing Loss, Unilateral

Intervention / Treatment
-----------------
* Device: Ponto Sound processor


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Online consent form filled out Has been fitted with at least one Ponto Sound Processor Exclusion Criteria: No exclusion criteria

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Ponto Users<br>Users that have been fitted with a Bone Anhcored Sound Processor, Ponto | Device: Ponto Sound processor<br>* Bone Anchored Hearing solution fitted to compensate for the subjects hearing loss<br>|

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 to best outcome. 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 |
| --- | --- | --- |
| Factor 1 IOI-HA score | 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 | at enrollement | 
| Factor 2 IOI-HA score | 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 | at enrollment | 
| Per item IOI-HA score | 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 | at enrollment | 
| Usage | Evaluate non-usage among patients fitted with a Ponto sound processor | at enrollment | 
| Upgrade | Evaluate Ponto sound processor upgrade rate | enrollment |