Hearing Loss
Conditions
Brief summary
The goal of this exploratory interventional study is to evaluate a new hearing aid noise-reduction strategy in experienced hearing aid users, compared to currently available strategies. The primary objective is to measure speech in noise performance with a new strategy and compare to the performance with currently available strategies via a coordinate response measure task.
Interventions
DEVICEPhonak Audeo Infinio Sphere
Experimental device
DEVICEHearing aid B
Active comparator device from different manufacturer that is currently available
DEVICEHearing aid C
Active comparator device from different manufacturer that is currently available
Sponsors
Sonova AG
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
Participants will be blinded as to which device they are wearing for testing.
Intervention model description
Participants will undergo multiple speech in noise tasks and a listening effort task with a Phonak hearing aid and two comparator hearing aids.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* bilateral and symmetrical severe hearing loss * experienced hearing aid user 6 months+ hearing aid use * good understanding of English language * able and willing to wear RIC style hearing aids with custom earpieces
Exclusion criteria
* unilateral hearing loss * mild hearing loss * inability to follow verbal directions * presence of ear infection, middle ear fluid, dizziness, or worsening of hearing loss within last 90 days
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Coordinate Response Measure | 1 day (lab visit 2) | Test measures speech perception in the presence of 5 competing talkers, presented from 5 speakers located in front of the participant. The talkers are presented sequentially with a brief offset of 1.2 seconds. One of the talkers is the target talker and the participant is instructed to listen for a specific call sign, which identifies the target talker. The participant is prompted to identify the color and number that is subsequently spoken by the target talker. The location of the target talker is randomized from the five locations in the front hemisphere. A score of correctly repeated color and number is calculated and a higher score is better. The dB levels at which the target talker and competing talkers are presented are determined individually for each participant by the Speech in Noise Test, described in Outcome 4. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| ACALES (Adaptive Categorical Listening Effort Scaling) | 1 day (lab visit1) | An adaptive method of measuring subjective listening effort. Three sentences are presented sequentially in noise. The listener rates their subjective effort on a 13-point scale that goes from Effortless (1) to Extremely Effortful (13). There is a 14th point which is labeled "Only Noise" and indicates no speech was heard. After each rating, the volume of the speech adapts. The algorithm is designed to capture the SNR (Signal to Noise Ratio) that includes both the effortless and the extremely effortful rating for an individual. Listeners rate different SNR levels using the scale, for instance, a listener may rate an SNR of -12 dB (where speech is 12 dB softer than the noise) as Very Effortful, or 11 on the scale, while rating a SNR of -2 (where speech is only 2 dB softer than noise) as Effortless or a 1 on the scale. In comparing HA settings, that which has the least negative SNR for a particular rating on the scale indicates less effort. |
| Subjective Rankings of Each Hearing Aid | 1 day (lab visit 1) | Participants ranked the three devices on a scale from 1 (worst) to 5 (best) for five characteristics: Noise suppression, overall satisfaction, speech clarity, speech loudness, speech naturalness. For each participant, ranks were assigned to each device based on the rating it received, with 1 being the highest rank and 3 being the lowest rank. The frequency of each rank was then calculated for each device across all raters. Results are displayed in the count of devices in each ranking. No statistical analysis was performed on this measure. |
Countries
United States
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 76.8 years STANDARD_DEVIATION 8.13 |
| Left Ear Pure Tone Average | 55.7 decibels STANDARD_DEVIATION 10.8 |
| Region of Enrollment United States | 17 Participants |
| Right Ear Pure Tone Average | 57.6 decibels STANDARD_DEVIATION 8.96 |
| Sex: Female, Male Female | 7 Participants |
| Sex: Female, Male Male | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 3 | 0 / 3 | 0 / 2 | 0 / 3 | 0 / 3 | 0 / 3 |
| other Total, other adverse events | 0 / 3 | 0 / 3 | 0 / 2 | 0 / 3 | 0 / 3 | 0 / 3 |
| serious Total, serious adverse events | 0 / 3 | 0 / 3 | 0 / 2 | 0 / 3 | 0 / 3 | 0 / 3 |
Outcome results
None listed