Speech Locator In-car Performance Evaluation

Study Overview
=================
Brief Summary
-----------------
Listeners will conduct sound quality ratings of recordings talkers in a moving car processed using three different microphone processing strategies: an investigational adaptive directional microphone, an omnidirectional microphone and a fixed directional microphone. Participants will listen to the recordings streamed via commercially-available and individually-prescribed hearing aids, and conduct ratings onsite in the lab. The procedure will involve a training session and within-subject repeated measures. Stimuli will be randomized.

Official Title
-----------------
Speech Locator In-car Performance Evaluation

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

Intervention / Treatment
-----------------
* Device: Investigational adaptive directional microphone strategy
* Device: Comparator omnidirectional microphone strategy
* Device: Comparator fixed directional microphone strategy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults (18-99 years) with ≥3 months hearing aid experience binaural, symmetric, sensorineural N2 (mild) to N5 (severe) hearing loss fluent in English Exclusion Criteria: children/teenagers normal hearing or hearing loss exceeding N5 (severe) by 10 dB

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Investigational adaptive directional microphone strategy<br>Receiver-in-canal hearing aid with an investigational adaptive directional microphone strategy. | Device: Investigational adaptive directional microphone strategy<br>* A receiver-in-canal hearing aid developed by the Study Sponsor used with the investigational adaptive directional microphone strategy that is expected to improve sound quality of speech in a car.<br>|
| Active Comparator: Comparator omnidirectional microphone strategy<br>Receiver-in-canal hearing aid with a comparator omnidirectional microphone strategy. | Device: Comparator omnidirectional microphone strategy<br>* A receiver-in-canal hearing aid developed by the Study Sponsor used with the comparator omnidirectional microphone strategy that is used with the default settings as specified in the manufacturer's fitting software.<br>|
| Active Comparator: Comparator fixed directional microphone strategy<br>Receiver-in-canal hearing aid with a comparator fixed directional microphone strategy. | Device: Comparator fixed directional microphone strategy<br>* A receiver-in-canal hearing aid developed by the Study Sponsor used with the comparator fixed directional microphone strategy that is used with the default settings as specified in the manufacturer's fitting software.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sound quality rating | The sound quality ratings will be conducted via a computer-based questionnaire that contains sound samples that participants listen to and rate. Sound quality rating scales are continuous and range from 0 (worst) to 100 (best) with 5 descriptors unique to the dimension at 5 intervals on the scale (0, 25, 50, 75, 100) Dimensions rated are: Speech clarity: Very unclear, Unclear, Slightly clear, Clear, Very clear Noise annoyance: Extremely annoying, Very annoying, Moderately annoying, Slightly annoying, Not at all annoying Spatialization: I don't know where the talker is, the talker might be [at location], The talker is probably [at location], The talker is [at location], The talker is definitely [at location] Overall impression: Bad, Poor, Fair, Good, Excellet Transition annoyance: Extremely annoying, Very annoying, Moderately annoying, Slightly annoying, Not at all annoying | Up to 6 hours over 3 2-hour sessions |