Hearing Loss
Conditions
Brief summary
The goal of this interventional study is to evaluate the DNN Noise reduction feature of Phonak hearing aids in adults with moderate to moderate severe hearing loss. The main questions it aims to answer are: Do participants correctly identify significantly more words on the AZBio Sentence Test when using Phonak's DNN NR feature than when using Competitor device A in a lab setting? Do participants subjectively rate the speech clarity, ease of listening, and listening confidence higher when using Phonak's DNN feature than when using Competitor device A in both a lab setting and a real-world cafe setting? Do participants have an overall preference for the Phonak device over the Competitor device A in a real-world cafe setting? Participants will be fit with both the Phonak device and a Competitor device A in the lab. They will be given the AZBio Sentence test and repeat as many words as they can in a simulated noisy environment. Following the lab visit, participants will meet in a group with three other conversation partners in a real-world setting and asked to complete subjective questionnaires during the visit.
Detailed description
Participants will undergo a hearing aid fitting for both the Phonak device and the Competitor device A. In the lab, participants will be seated in the center of a 10-speaker array. Diffuse ecologically valid noise will be coming from all 10 speakers, while recorded sentences will be presented one at a time randomly from 4 speakers in front of the participant. Participants will be given two lists of 25 sentences for each hearing aid condition, and will repeat as many words as they can. Percentage correct will be calculated for each hearing aid condition. The second appointment will consist of a real-world visit to a local cafe, in which they will be seated at a table with three other conversation partners. During the cafe visit, participants will be asked to answer questions about their perceived speech clarity, ease of listening, and listening confidence with each of the two devices. Participants will be blinded as to which devices they are wearing for both the lab visit and the real world cafe visit.
Interventions
Phonak Audeo Infinio RIC
DEVICECompetitor Device A
Competitor Device A
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 hearing aid they are wearing during all of the testing.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adults (18+ years old) with audiograms within fitting range of the hearing aid (e.g., moderate to severe sensorineural hearing losses {N3-N5}) and with hearing aid experience will be recruit-ed for this study. * Ability to fill out questionnaires * No known cognitive issues. * Fluent in English, ability to read and write in English. * Informed consent documented by signature. * Willingness to wear binaural receiver-in-canal (RIC) devices with domes. * Willingness to meet up outside of the lab at a local café with two other consented research participants.
Exclusion criteria
* Contraindications to medical device (MD) in this study: known hypersensitivity or allergy to investigational product/domes. * Limited mobility/not being able to come to scheduled appoint-ments. * Limited ability to describe listening impressions/experiences and the use of the hearing aid. * Known psychological disorders.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| AZBio Sentence Test | Day 1 of study | A validated speech perception test consisting of 25 different lists of sentences. Sentences are presented via a loudspeaker at a pre-determined level and the number of words correctly repeated are calculated into a percenteage. The higher the percentage, the better the participant's speech perception. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Composite Questionnaire | Days 1 and 2 of study | A 5-point Likert scale questionnaire that asks participants to rate the speech clarity, ease of listening, and listening confidence for each hearing aid. The scale is from 1 = Strongly disagree, to 5 = Strongly agree. Participants will be given this questionnaire following the AZBio Sentence test in the lab, and following the group conversation in the cafe. |
Countries
United States
Outcome results
None listed