Assessing Listening Effort at Different Signal-to-noise Ratios in Bone-anchored Users

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess listening effort during a speech-in-noise task in bone-anchored hearing systems (BAHS) users via pupillometry.

Detailed Description
-----------------
Pupil dilation can be used as an objective indicator of listening effort during the execution of a task. The aim is to compare listening effort with different settings (OpenSound Navigator ON and OFF) of Ponto 4, the sound processor released by Oticon Medical AB in June 2019, in listening scenarios that differ in complexity. The study consists of three visits of about two hours each in duration, during which the patients will perform a speech-in-noise task where the listening task varies in difficulty (i.e., in terms of signal-to-noise ratio, SNR). Pupil dilation will be recorded during the listening task as an indicator of listening effort. The patients will also use Ponto 4, instead of their own Ponto device, during a field-trial period of three months in between visit 2 and 3. Subjective evaluations of Ponto 4 will be performed via three questionnaires, one regarding self-reported performance in everyday life, one regarding work-related fatigue, and one regarding overall sound processor preference (Ponto 4 vs. patient's own device). All these outcome measures are non-invasive measurements. This is a post market study and all products used are CE marked and used in clinical practice worldwide.

Official Title
-----------------
Assessing Listening Effort at Different Signal-to-noise Ratios in Bone-anchored Users

Conditions
-----------------
Bilateral Hearing Loss

Intervention / Treatment
-----------------
* Device: Fitting of Ponto 4


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Minimum 18 years and maximum 70 years old. UK English mother tongue. Bilateral conductive or mixed hearing loss. Users fitted unilaterally or bilaterally on abutment. Users are currently fitted with either Ponto 3, Ponto Plus or Ponto Pro (devices with a fitting range up to 45 dB HL). Users with at least 6 months of daily experience with one Ponto sound processor. BC thresholds of the implanted ear(s) better (lower) than or equal to 40 dB HL (average of 0.5, 1, 2 and 3 kHz) based on BC in-situ measurement at the first visit. People currently employed/self-employed (since the Need for Recovery questionnaire refers to work-related fatigue). Speech recognition scores better (higher) than or equal to 50% at +4 dB SNR with OSN OFF (as assessed via the first training list at Visit 1). This is to avoid including patients that are already giving up at +4 dB SNR. Users entitled for a sound-processor upgrade (according to the investigator) will first be selected. If there are not enough users entitled for an upgrade, then patients fitted with Ponto between 7 and 12 months before visit 1 will be considered. If there are not enough users within 7-12 months, then patients fitted with Ponto between 13 and 18 months before visit 1 will be considered. Exclusion Criteria: Single-sided deafness (SSD) Hearing aid or cochlear implant on the opposite ear. Test persons with current eye diseases and/or history of eye surgery on both eyes. If the patient takes medications that can impact the autonomic nervous system - and hence pupil dilation (e.g., drugs for Parkinson's disease, peptic ulcers, incontinence, motion sickness). If the investigator or physician assesses that the patient is not fit for trial participation.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ponto 4 sound processor<br>All patients will be fitted with a bone-anchored sound processor (Ponto 4), unilaterally or bilaterally. | Device: Fitting of Ponto 4<br>* Bone-anchored hearing systems (BAHS) use the body's natural ability to transfer sound through bone conduction. The sound processor picks up sound and converts it into vibrations that are transferred through the skull bone to the inner ear (cochlea). Thus, for patients with conductive or mixed hearing losses, patients with lasting hearing loss following a middle ear disease or malformations (such as microtia), the vibrations are bypassing the conductive problem in the ear canal or middle ear. The intervention in this study is audiologically fitting one/two bone-anchored sound processors (Ponto 4) to patients that are already implanted with abutments.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall pupil dilation | Overall pupil dilation for OSN ON and OSN OFF at +4 dB SNR | 10 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peak and overall pupil dilation | Pupil dilation at different SNRs | 10 days | 
| Growth Curve Analysis parameters. | GCA at different SNRs | 10 days | 
| Speech recognition scores | Performance (% correct) at different SNRs | 10 days | 
| Speech Spatial and Qualities of Hearing scale (SSQ) questionnaire scores | Self-reported perception before, during, and after field trial. The SSQ questionnaire consists of 49 items with a scale from 0-10 where 0 represents Not at all and 10 represents Perfect. | 4 months | 
| Preference questionnaire scores. | Self-reported preference after field trial. The preference questionnaire consists of 11 questions. The scores are from 1 to 5, where 1 means Own sound processor much better and 5 means Test sound processor much better. | 4 months | 
| Aided sound field thresholds | Sound field audiometry performed with the Auricle system while the patient is wearing the Ponto sound processor. This measurement is conducted at 10 frequencies from 250 Hz to 8 kHz. | 4 months | 
| BC in situ thresholds. | Hearing level thresholds (dB HL) as assessed in situ with Ponto 4 placed on the patient's abutment. Bone-conduction thresholds (BC) are measured as the softest sound level that is audible by the patient at 10 frequencies from 250 Hz to 8 kHz. | 1 hour | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Bone anchored hearing systems, BAHS, Listening effort, Pupillometry, Ponto 4