Subject´s Preference Regarding Hearing Performance and Functionality Using a New Sound Processor

Study Overview
=================
Brief Summary
-----------------
The aim of this clinical investigation is to investigate the subject´s overall preference, hearing performance and self-reported assessments with the Investigational device and its precursor Sound Processor (Comparator) after 6 weeks in subjects with conductive/mixed hearing loss or Single Sided Deafness, (SSD).

Official Title
-----------------
Subject´s Preference Regarding Hearing Performance and Functionality Using a New Sound Processor

Conditions
-----------------
Deafness; Sensoneural Single Sided, Conductive Hearing Loss, Mixed Hearing Loss

Intervention / Treatment
-----------------
* Device: Investigational device - Sound Processor


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Completed clinical investigation CBAS5539, and an active user of the Osia System. Signed Informed consent. Subject with conductive or mixed hearing loss in the implanted ear. Bone conduction thresholds with pure tone average (PTA4; mean of 0.5, 1, 2 and 4 kHz) of ≤ 55 dB HL. OR subject with single-sided sensorineural deafness. Air conduction thresholds with a pure tone average PTA4 of ≤ 20 dB (decibel) HL (Hearing Level) (mean of 0.5, 1, 2 and 3 kHz) in the good ear. - Optimally fitted with Osia Sound processor, according to subject's experience prior to inclusion. Exclusion Criteria: Any ongoing soft tissue complication that could significantly affect the use of the Osia 2 Sound Processor during the 6 weeks period Use of ototoxic drugs that could be harmful to the hearing, as judged by the investigator Unable to follow investigational procedures and instructions, e.g. inability to complete quality of life scales or audiological testing as described in the Clinical Investigation Plan (CIP). Participation in another clinical investigation with pharmaceutical and/or device.

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

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

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

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

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Investigational device - Sound Processor<br> | Device: Investigational device - Sound Processor<br>* At visit 1 the subjects will complete self-reported assessments with respect to pre-study experience using precursor Sound Processor (comparator). At visit 1 the subjects will then receive the Investigational device (Sound Processor) which should be used during the following 6 weeks. At visit 3 the subjects will complete self-reported assessments regarding Investigational device and participate in audiology tests regarding both Sound Processors, comparator and Investigational device. The subject shall decide their preferred choice made by selection between Investigational device and the comparator.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Abbreviated Profile of Hearing Aid Benefit (APHAB) | Measuring of subscales Ease of communication, Reverberation, Background noise, Aversiveness and a Global score with the precursor sound processor at Day 0 and with the Investigational device after 6 weeks with a questionnaire. All subscales range from 0-100%, total score is the average of all subscales 0-100%, where 0% indicates no problems and 100% indicates always problem. A decrease in the APHAB values indicates an improvement. The change from visit 1 with the precursor sound processor to visit 3 with the Investigational device is presented. A positive value indicates an improvement with the Investigational device, a negative value an impairment. | Day 0 (Visit 1) and after 6 weeks (Visit 3) | 
| Speech, Spatial, and Qualities of Hearing Scale (SSQ) | Measuring speech, spatial and hearing experiences with the precursor sound processor at Day 0 (Visit 1) and with Investigational device after 6 weeks (Visit 3) with a questionnaire. The Total score summarizes the parameters speech, spatial and hearing. A scale from 0 to 10, where 0 represents can not hear at all, and 10 hear perfectly is used. An increase of a SSQ value reflects an improvement. The change from visit 1 with the precursor sound processor to visit 3 with the Investigational device is presented. A positive value indicates an improvement and a negative value an impairment. | Day 0 and after 6 weeks | 
| Self-reported Assessment Regarding Satisfaction and Usability (QUEST Version 2) | Measuring QUEST (Self-reported assessment regarding satisfaction and usability) using a questionnaire, with the precursor sound processor at Day 0 (Visit 1) and with the Investigational device after 6 weeks (Visit 3). The QUEST form displays the scoring of 8 satisfaction items. The satisfaction items related to the characteristics of the device are: 1) dimensions, 2) weight, 3) adjustments, 4) safety, 5) durability, 6) simplicity of use, 7) comfort and 8) effectiveness. A scale from 1 to 5, where 1 represent not satisfied at all, 2 not very satisfied, 3 more or less satisfied, 4 quiet satisfied and 5 represents very satisfied. The three most important items of 1) dimensions, 2) weight, 3) adjustments, 4) safety, 5) durability, 6) simplicity of use, 7) comfort and 8) effectiveness were listed by each participant. | Day 0 and after 6 weeks | 
| Audiometric Thresholds in Freefield, Pure Tone Average 4 (PTA4) | To measure threshold audiometry PTA4 (mean of 500, 1000, 2000 and 4000 Hz) with both the precursor sound processor and the Investigational device. The units reported for PTA4 are decibels (dB). The change from visit 1 with the precursor sound processor to visit 3 with the Investigational device is presented. As such, a lower or more negative score is more desirable and reflects a better ability to hear softer sounds. | Baseline at visit 1, 6 weeks after study start at visit 3 | 
| Audiometric Thresholds in Freefield, Individual Frequencies | To measure threshold audiometry at individual frequencies 250, 500, 1000, 2000, 3000, 4000, 6000 Hz with both the precursor sound processor and the Investigational device. The units reported for threshold audiometry are decibels (dB). The change from visit 1 with the precursor sound processor to visit 3 with the Investigational device is presented. As such, a lower or more negative score is more desirable and reflects a better ability to hear softer sounds. | 6 weeks after study start | 
| Adaptive Speech Recognition in Noise Ratio | To measure Adaptive speech recognition in noise with the precursor sound processor and the Investigational device. Measured as signal to noise ratio The adaptive speech test in noise was conducted using validated lists of phonetically balanced sentences, with speech and noise presented from the front (0 degrees azimuth). The speech is kept constant at 65 dB Sound Pressure Level (SPL) and the noise is adapted in dB steps to establish the speech-to-noise ratio (SNR) providing a 50% level of understanding. A ratio of 1 reflects the ability to correctly hear sentences at 65 dB, in the presence of 65 dB background noise. A lower ratio than 1 reflects the ability to correctly hear sentences below 65 dB. A ratio higher than 1 reflects the ability to correctly hear sentences presented above 65 dB. A lower or more negative score is more desirable and represent a better hearing in a noisy environment. | Baseline at visit 1, 6 weeks after study start at visit 3 | 
| Speech in Quiet | To measure Speech in quiet at 50, 65 and 80 dB with the precursor sound processor and the Investigational device. Speech in Quiet presents a list of words in a quiet environment at three different presentations levels, 50, 65 and 80 dB (decibel). The number of correct words perceived at each presentation level are counted and the percentage in relation to the total presented amount of words is calculated. A higher score reflects a higher percentage of correct words perceived, i.e. better hearing in a quiet environment. | Baseline at visit 1, 6 weeks after study start at visit 3 | 
| To Compare the Subject´s Overall Preference Regarding the Investigational Device and the Precursor Sound Processor | The test subject will be asked a question regarding preferred choice made by selection between Investigational device and the precursor sound processor (comparator). Three boxes can be ticked; Precursor Sound Processor, Investigational Device, No preference. | 6 weeks after study start | 
| To Assess the Subject's Experience Regarding Comfort | Measure Comfort by a visual analogue scale (VAS) 100 mm at Day 0 regarding the precursor sound processor and after 6 weeks regarding the Investigational device. Subject will be asked to put a line where they find most appropriate where 0 mm represents Not comfortable at all and 100 represents Most comfortable imaginable. The distance will be measured with a ruler and presented as a value between 0 and 100. A higher score reflects higher comfort. | Baseline at visit 1, 6 weeks after study start at visit 3 | 
| To Assess the Subject's Experience Regarding Usage; Magnet Choice | Magnet choice will be entered; four boxes are available, 1, 2, 3 and 4, the box with the strength chosen by the patient will be ticked. Magnet strength 1 is the weakest and 4 is the strongest. | 6 weeks after study start | 
| To Assess the Subject's Experience Regarding Usage; Battery Life Time | The patient will be asked a question regarding battery life; How often was the battery changed. A free text field is available for answer. | 6 weeks after study start | 
| To Assess the Subject's Experience Regarding Usage; Softwear Pad | The patient will be asked a question Did you use a SoftWear Pad in the last 6 weeks. The patient can tick a Yes or No box. | 6 weeks after study start | 
| To Assess the Subject's Experience Regarding Usage; Safety Line | The patient will be asked a question Did you use a safety line in the last 6 weeks. The patient can tick a Yes or No box. | 6 weeks after study start | 
| To Assess the Subject's Experience Regarding Usage; Wireless Accessories | The patient will be asked a question Did you use a Wireless accessory during the last 6 weeks. The patient can tick a Yes or No box. | 6 weeks after study start |