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

Not Applicable

Terminated

Conditions: Bilateral Hearing Loss

Interventions: Device: Fitting of Ponto 4

Registration Number: NCT04242940

Lead Sponsor: Oticon Medical

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.

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 14

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Ponto 4 sound processor	Fitting of Ponto 4	All patients will be fitted with a bone-anchored sound processor (Ponto 4), unilaterally or bilaterally.

Primary Outcome Measures

Name	Time	Method
Overall Pupil Dilation	10 days	Overall pupil dilation for OSN ON and OSN OFF at +4 dB SNR a third-order polynomial function was fit to the pupil dilation data, with the OSN setting as a fixed factor, as well as the interaction of OSN with each of the polynomial time terms. The formula used is the following: Pupil Dilation = (Linear + Quadratic + Cubic) X OSN setting + (1 + Linear + Quadratic + Cubic\\| Subject); where the Linear, Quadratic, and Cubic are the orthogonal terms; X indicates the interaction with OSN setting, and the terms reported in the second parenthesis are the random factors. The random factors include the effect of listeners, and of each of the time terms, to account for the variability in the time course of dilation across listeners. Outcome measure is the percentage reduction(% change) in pupil dilation with OSN ON vs OSN OFF

Secondary Outcome Measures

Name	Time	Method
Peak Pupil Dilation (PPD) for OSN ON and OSN OFF	10 days	The difference in pupil dilation between OSN ON and OSN OFF was also analyzed via Peak Pupil Dilation (PPD); thus, by investigating differences in dilation at the peak of the curve. The PPD was obtained for each subject as the maximum dilation between 7.5 and 9 s.
Speech Recognition Scores With OSN ON vs. OSN OFF Across SNRs	10 days	A mixed-linear model with OSN setting (2 levels: ON and OFF) and SNR (5 levels: -8, -4, 0, +4, +8 dB) as fixed factors, and subject as random factor, was fit to the data.
Speech Spatial and Qualities of Hearing Scale (SSQ) Questionnaire Scores	4 months	Self-reported perception before, during (at 1 month), and after field trial (at 3months). The SSQ questionnaire consists of 49 items with a scale from 0-10 where 0 represents "Not at all" and 10 represents "Perfect". The SSQ questionnaire is comprised of three subscales domains (Speech, Spatial, and Qualities of Hearing) - that is, each of the 49 items fits into one of these subscale "categories". The subscale scores AND the total scores (the total score is comprised of all of the 49 items) use the same scale of 0 to 10 where 0 represents "Not at all" and 10 represents "Perfect". For the total scale and all subscales (again all questions and by extension, the scales range from 0 to 10) the higher the value (closer to 10) represents a better outcome than lower values (closer to 0).
Preference Questionnaire Scores.	4 months	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 \[Ponto 4\] much better".
Aided Sound Field Thresholds	4 months	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. The Pure tone threshold is calculated as the average across .5, 1, 2, \& 3 kHz)
BC in Situ Thresholds.	1 hour	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. The Pure tone threshold is calculated as the average across .5, 1, 2, \& 3 kHz