Hearing Loss
Conditions
Keywords
Mild to moderate hearing loss
Brief summary
Randomized post market study comparing Lyric to Lyric2 capturing information regarding comparative performance and safety.
Detailed description
Randomized post market study comparing extended wear hearing aids Lyric to Lyric2 capturing information regarding comparative performance and safety.
Interventions
DEVICELyric
Extended wear hearing instrument
DEVICELyric2
Extended wear hearing instrument
Sponsors
Phonak AG, Switzerland
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Aged 18-90 years at the time of enrollment in the study * Mild to moderately-severe hearing loss bilaterally, or unilaterally if normal hearing in other ear * Fluent in English * Willingness to comply with all study requirements
Exclusion criteria
* Scuba dives or sky dives * Underwater swimming or dives into the water * Handicaps that would restrict participation in all the evaluations * Hearing loss of neural or central origin * Unrealistic expectations regarding benefits and limitations inherent in the devices * Chemotherapy within the last six months * Compromised immune system * Radiation to head or neck * Perforated tympanic membrane * History of cholesteatoma * Active outer or middle ear pathology * High levels of anticoagulant therapy * Insulin-dependent and/or uncontrolled diabetes * Contact dermatitis * Bleeding disorder * Unwillingness or inability to comply with all study requirements
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Immediate Refit Upon Device Removal | Following device removal at the same appointment (Up to 24 hours after removal) | Upon device removal, a qualified audiologist examined subjects' ears to evaluate their availability to be immediately refit with another hearing aid device. It is not uncommon for patients being fitted with these types of devices to experience slight irritation on an initial experience with the device. In particular, those being fit with the Lyric or Lyric2.0 for the first time first undergo the device sizing process, which slightly increases stress on the ear. |
Secondary
| Measure | Time frame |
|---|---|
| Gain, Speech Understanding and Sound Quality | During useful lifespan of device |
| Device Comfort | During useful lifespan of device |
Countries
United States
Participant flow
Recruitment details
Patients are fitted according to their ear size and experience level. Patients with a different experience level for each ear are only counted once.
Participants by arm
| Arm | Count |
|---|---|
| Lyric Silver Lyric device
Lyric: Extended wear hearing instrument | 70 |
| Lyric2 Lyric2 (Barracuda) device
Lyric: Extended wear hearing instrument | 107 |
| Total | 177 |
Baseline characteristics
| Characteristic | Lyric | Lyric2 | Total |
|---|---|---|---|
| Age, Customized <=18 years of age | 0 participants | 0 participants | 0 participants |
| Age, Customized >18 years of age | 70 participants | 107 participants | 177 participants |
| Region of Enrollment United States | 70 participants | 107 participants | 177 participants |
| Sex: Female, Male Female | 13 Participants | 35 Participants | 48 Participants |
| Sex: Female, Male Male | 57 Participants | 72 Participants | 129 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 4 / 70 | 6 / 107 |
| serious Total, serious adverse events | 0 / 70 | 0 / 107 |
Outcome results
Primary
Immediate Refit Upon Device Removal
Upon device removal, a qualified audiologist examined subjects' ears to evaluate their availability to be immediately refit with another hearing aid device. It is not uncommon for patients being fitted with these types of devices to experience slight irritation on an initial experience with the device. In particular, those being fit with the Lyric or Lyric2.0 for the first time first undergo the device sizing process, which slightly increases stress on the ear.
Time frame: Following device removal at the same appointment (Up to 24 hours after removal)
Population: Only ears from experienced users were taken into account, i.e. only users that have previously worn an extended wear device. Some patients previously worn only one hearing instrument, therefor a significant number of patients were only fitted with one instrument
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Lyric | Immediate Refit Upon Device Removal | 78 percentage of ears |
| Lyric2 | Immediate Refit Upon Device Removal | 93 percentage of ears |
Secondary
Device Comfort
Time frame: During useful lifespan of device
Secondary
Gain, Speech Understanding and Sound Quality
Time frame: During useful lifespan of device