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

Sponsor

Oticon Medical (Industry)

Overall Status

Recruiting

CT.gov ID

NCT04242940

Collaborator

(none)

Enrollment

Location

Arm

20.3

Anticipated Duration (Months)

1.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Bilateral Hearing Loss	Device: Fitting of Ponto 4	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Masking Description:

The participants are however blinded to the Ponto 4 setting (OpenSound Navigator ON/OFF in Ponto 4) activated for each list of sentences.

Primary Purpose:

Basic Science

Official Title:

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

Actual Study Start Date :

Feb 21, 2020

Anticipated Primary Completion Date :

Jun 30, 2021

Anticipated Study Completion Date :

Oct 30, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Ponto 4 sound processor All patients will be fitted with a bone-anchored sound processor (Ponto 4), unilaterally or bilaterally.	Device: Fitting of Ponto 4 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.

Arm

Intervention/Treatment

Experimental: Ponto 4 sound processor

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

Device: Fitting of Ponto 4

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.

Outcome Measures

Primary Outcome Measures

Overall pupil dilation [10 days]
Overall pupil dilation for OSN ON and OSN OFF at +4 dB SNR

Secondary Outcome Measures

Peak and overall pupil dilation [10 days]
Pupil dilation at different SNRs
Growth Curve Analysis parameters. [10 days]
GCA at different SNRs
Speech recognition scores [10 days]
Performance (% correct) at different SNRs
Speech Spatial and Qualities of Hearing scale (SSQ) questionnaire scores [4 months]
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".
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 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.
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.

Other Outcome Measures

Need for Recovery (NFR) questionnaire scores. [4 months]
Self-reported work-related fatigue. The NFR scale is an 11-item scale assessing the effects of fatigue caused by work (e.g., " I find it hard to relax at the end of a working day"). Possible responses are "yes" or "no". The total NFR score is the number of "yes" responses divided by the total number of items, presented as a percentage (i.e., range 0-100). The higher the score, the greater the NfR felt by the respondent.
Pupil dilation after field trial. [4 months]
Change in pupil dilation after field trial to check for acclimatization effects.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.