Hearing Loss
Conditions
Brief summary
New and experienced hearing aid users will be fit with two hearing devices. One will be labeled as an OTC (Over-The-Counter) device, the other will be labeled as a Prescriptive (i.e. professionally fit) device. Both devices will be generically programmed for a mild to moderate hearing loss. An objective speech in noise test will be completed with both devices.
Interventions
DEVICEAudeo P hearing aid labeled as Prescriptive
The Audeo P is a commercially available hearing aid that is fit by a hearing care professional. The devices will be labeled as prescriptive in view of the participant.
DEVICEAudeo P hearing aid labeled as OTC
The Audeo P is a commercially available hearing aid that is fit by a hearing care professional. The devices will be labeled as OTC in view of the participant.
Sponsors
Sonova AG
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Masking description
Participants will be told they are wearing either a prescriptive hearing aid or an OTC (Over-The-Counter) hearing device based on the labeling of the hearing aids. Both sets of devices will actually be the same. The investigator that is scoring the objective speech in noise test will not know which device the participant is wearing at the time of the test (i.e., the set that is labeled as prescriptive or the set that is labeled as OTC).
Intervention model description
A single group of participants will be involved in this study. All participants will be evaluated with both hearing devices.
Eligibility
Sex/Gender
ALL
Age
18 Years to 95 Years
Healthy volunteers
Yes
Inclusion criteria
* Adults age 18 or older with bilateral mild to moderate hearing loss * Experienced users must have at least 6 months Hearing Aid experience * New users must have no prior hearing aid experience, defined as never owning their own devices
Exclusion criteria
* Self-reported ear related pathology (otorrhea w/in 90 days, dizziness, sudden hearing loss or worsening of hearing w/in 90 days, otalgia) * Visible deformity of the ear * Chronic, severe tinnitus * Unilateral hearing loss * Cognitive impairment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quick Speech in Noise Test (QuickSIN) | Day 1 of 1 day study | A speech in noise test in which participant repeats sentences in variable levels of background noise. Test result is reported as the signal to noise level at which participant can repeat 50% of the words correctly. A lower score/dB SNR (decibel Signal to Noise Ratio) level indicates better speech in noise perception. For example, a score of 0 dB would indicate that the participant can repeat 50% of the words presented when the speech signal and the noise are presented at the same level. A score of 6 dB would indicate that the participant needs the speech signal 6 dB louder than the noise in order to correctly repeat 50% of the words presented. Scores can range from negative db SNR (e.g. -5 dB, which would be a good score and indicate little difficulty in noise) to quite high (e.g. +15 dB, which would be a poorer score and indicate much difficulty in noise) In this case, the scores ranged from +2 to +18 dB. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Naive Listeners Participants who have not worn hearing aids before. These participants will be tested with both sets of Audeo P hearing aids. One set will be labeled as OTC and the other set will be labeled as Prescriptive.
Audeo P hearing aid labeled as Prescriptive: The Audeo P is a commercially available hearing aid that is fit by a hearing care professional. The devices will be labeled as prescriptive in view of the participant.
Audeo P hearing aid labeled as OTC: The Audeo P is a commercially available hearing aid that is fit by a hearing care professional. The devices will be labeled as OTC in view of the participant. | 10 |
| Experienced Users Participants who haveat least 6 months of experience with hearing aids. These participants will be tested with both sets of Audeo P hearing aids. One set will be labeled as OTC and the other set will be labeled as Prescriptive.
Audeo P hearing aid labeled as Prescriptive: The Audeo P is a commercially available hearing aid that is fit by a hearing care professional. The devices will be labeled as prescriptive in view of the participant.
Audeo P hearing aid labeled as OTC: The Audeo P is a commercially available hearing aid that is fit by a hearing care professional. The devices will be labeled as OTC in view of the participant. | 10 |
| Total | 20 |
Baseline characteristics
| Characteristic | Experienced Users | Total | Naive Listeners |
|---|---|---|---|
| Age, Continuous | 76.8 years | 73.4 years | 70 years |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 10 participants | 20 participants | 10 participants |
| Sex: Female, Male Female | 7 Participants | 14 Participants | 7 Participants |
| Sex: Female, Male Male | 3 Participants | 6 Participants | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 10 | 0 / 10 |
| other Total, other adverse events | 0 / 10 | 0 / 10 |
| serious Total, serious adverse events | 0 / 10 | 0 / 10 |
Outcome results
Primary
Quick Speech in Noise Test (QuickSIN)
A speech in noise test in which participant repeats sentences in variable levels of background noise. Test result is reported as the signal to noise level at which participant can repeat 50% of the words correctly. A lower score/dB SNR (decibel Signal to Noise Ratio) level indicates better speech in noise perception. For example, a score of 0 dB would indicate that the participant can repeat 50% of the words presented when the speech signal and the noise are presented at the same level. A score of 6 dB would indicate that the participant needs the speech signal 6 dB louder than the noise in order to correctly repeat 50% of the words presented. Scores can range from negative db SNR (e.g. -5 dB, which would be a good score and indicate little difficulty in noise) to quite high (e.g. +15 dB, which would be a poorer score and indicate much difficulty in noise) In this case, the scores ranged from +2 to +18 dB.
Time frame: Day 1 of 1 day study
Population: All participants who were tested with the devices labeled as OTC and with devices that were labeled as Prescriptive in the same test session.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Naive Listeners | Quick Speech in Noise Test (QuickSIN) | dB SNR with OTC labelled devices | 6.2 decibels (dB) |
| Naive Listeners | Quick Speech in Noise Test (QuickSIN) | dB SNR with Prescriptive labelled devices | 5.2 decibels (dB) |
| Experienced Users | Quick Speech in Noise Test (QuickSIN) | dB SNR with OTC labelled devices | 9.6 decibels (dB) |
| Experienced Users | Quick Speech in Noise Test (QuickSIN) | dB SNR with Prescriptive labelled devices | 10 decibels (dB) |
p-value: >0.05t-test, 2 sided
p-value: >0.05t-test, 2 sided