An interventional study of Device A and Device B in Hearing Loss, Hearing Loss, Conductive and Hearing Loss, Mixed, sponsored by Oticon Medical. Completed at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-04-20.
Sponsored by Oticon Medical · Not applicable, Interventional, and Prevention
The study is a prospective, single-center, comparative, cross-over study with within-subject control design. In the investigation an updated sound processor will be tested at compared to the CE marked Ponto 3 SuperPower sound processor (available on the market since December 2016) in order to establish marketing claim(s) on the updated sound processor.
The performance of the two sound processors will be evaluated via speech and hearing tests, and patient reported outcomes.
The investigation is a premarket investigation with the purpose of gathering knowledge on the performance of an updated sound processor compared to the CE marked Ponto 3 SuperPower sound processor to establish marketing claim(s) on the updated sound processor.
The recruitment for this clinical investigation will be performed among subjects who have already received a Ponto 3 SuperPower sound processor as a minimum three month prior to the study. 12-15 adult Ponto 3 SuperPower users with a conductive, mixed hearing loss or single-sided deafness will be included.
The study is a prospective, single-center, comparative, cross-over study with within-subject control design. The study includes four laboratory visits and three field trial periods. After the first trial period, which is included to ensure a homogenous baseline, the study is designed as a two-period, two-sequence crossover trial to compare the two sound processors (Device A \& Device B). Each participant is randomized into one of two sequences: (1) Device A then B, or (2) Device B then A, such that (about) half of the participants are assigned to one sequence and the other half to the second sequence.
This study is designed to combine audiological assessments (hearing and speech tests) in the laboratory and subjective self-reported outcomes collected during and after field trial periods with the investigational device and the comparator device (Ponto 3 SuperPower). The primary outcome of this study is to demonstrate that Open Sound Navigator in the updated sound processor provides subjects with improved speech recognition in noise.
Subjects with:
Exclusion Criteria:
Subjects meeting any of the following criteria will not be permitted to participate in the investigation:
Starts with Device A in first and second trial period and change to Device B in third trial period.
Device: Device A · Device: Device B
Starts with Device A in first trial period, wears Device B in second trial period and change to Device A in third trial period.
Device: Device A · Device: Device B
Participant wear Device A and evaluate the performance of the device.
Participant wear Device B and evaluate the performance of the device.
To demonstrate that OSN in Device A provides subjects with improved speech recognition in noise.
Difference in signal-to-noise ratio at 70% correct (referred to as SRT70) between OSN OFF and OSN ON after field trial with Device A (incl. automatics).
Time frame: 4 weeks or 6 weeks
To assess the preference of BAHS sound processor.
Percentage (%) of subjects who prefer Device A over Device B in noisy sound environments.
Time frame: 6 weeks
To assess the improvement of hearing with Device A.
1. Functional gain with Device A, i.e. the difference in dB between unaided and aided sound field thresholds, for frequencies 250, 500, 1000, 2000, 3000, 4000, 6000 and 8000 Hz. 2. Functional gain with Device A, see definition above, calculated on average for frequencies 500, 1000, 2000 and 4000 Hz (PTA4).
Time frame: Baseline
To assess the degree to which Device A compensates for the BC hearing loss for the group CHL/MHL
1. Effective gain defined as the difference in dB between aided sound field thresholds with Device A, and BC in-situ thresholds on the aided ear(s). The effective gain is calculated for frequencies 250, 500, 1000, 2000, 3000, 4000, 6000 and 8000 Hz. 2. Effective gain with Device A, see definition above, calculated in average for frequencies 500, 1000, 2000 and 4000 Hz (PTA4).
Time frame: Baseline
To assess the improvement in speech recognition with Device A in quiet.
Difference in speech recognition score in percent between unaided and aided, assessed in quiet on the aided ear(s).
Time frame: 2 weeks
To assess performance in speech recognition in noise with Device A and Device B in Omni settings.
Difference in SRT70 between Device A and Device B in Omni settings as measured at Visit 1.
Time frame: Baseline
To assess the improvement in speech recognition in noise with Device B in full directional settings as compared to omnidirectional.
Difference in signal-to-noise ratio at 70% correct (referred to as SRT70) between Omni and Full Dir after field trial with Device B.
Time frame: 4 weeks or 6 weeks
To compare the improvement in speech recognition in noise with OSN ON in Device A (re Omni) with the improvement of full directionality in Device B (re Omni).
Comparison of the difference in SRT70 between OSN OFF vs. OSN ON in Device A and Omni vs. Full Dir in Device B.
Time frame: 4 weeks or 6 weeks
To assess self-reported performance with Device A and Device B.
1. Average SSQ12 scores with Device A for each question, sub-scales and in total. 2. Average SSQ12 scores with Device B for each question, sub-scales and in total. 3. Difference in SSQ12 scores between Device A and Device B for each question, sub-scales and in total.
Time frame: 4 weeks or 6 weeks
To assess self-reported ratings of sound quality, speech intelligibility, and overall performance with Device A and Device B.
1. Average ratings with Device A for each question of the "SPSK sound quality" questionnaire completed during the 1. field trial with Device A as obtained via phone interview 2. Average ratings with Device A for each question of the "SPSK sound quality" questionnaire completed during the 2. or 3. field trial with Device A 3. Average ratings with Device B for each question of the "SPSK sound quality" questionnaire completed during the 2. or 3. field trial with Device B 4. Difference in ratings between Device A and Device B for each question of the "SPSK sound quality" questionnaire 5. Average ratings with Device A for each question of the "SPSK situations" questionnaire completed during the 2. or 3. field trial with Device A 6. Average ratings with Device B for each question of the "SPSK situations" questionnaire completed during the 2. or 3. field trial with Device B 7. Difference in ratings between Device A and Device B for each question of the "SPSK situations" questionnaire
Time frame: 1 week, 4 weeks and 6 weeks
To assess the difference in BC thresholds as measured in-situ with Device A and via conventional BC audiometry.
Difference in dB between BC in situ thresholds and BC thresholds measured with conventional BC audiometry.
Time frame: Baseline and 2 weeks
To assess the difference in BC thresholds as measured in-situ with Device A and Device B.
Difference in dB between BC in situ thresholds measured with Device A and Device B.
Time frame: Baseline
To confirm the safety profile of the Device A in terms of the occurrence of adverse events and serious adverse events.
Tabulated adverse events and serious adverse event related to the Device A reported throughout the study.
Time frame: 1 week, 2 weeks, 4 weeks and 6 weeks
To assess the improvement in speech recognition in noise with Device A with OSN ON vs. OSN OFF as a function of hearing loss.
Correlation of the difference between OSN OFF and OSN ON after field trial with Device A (incl. automatics) and PTA4 BC in situ for subjects with SSD and subjects with conductive/mixed hearing loss.
Time frame: Baseline and week 4 or week 6
To list comments and reactions from the subjects with Device A and Device B.
Immediate reactions collected with each sound processor before field trial.
Time frame: Baseline, 2 weeks and 4 weeks
To list comments and reactions from the subjects with Device A and Device B.
Comments on any difference between phone interview and subject's feedback collected at V2 after first field trial with Device A (without automatics).
Time frame: 2 weeks
To assess usage of device for each field trial period.
Average hours of usage of each sound processor for each field trial.
Time frame: 2 weeks, 4 weeks and 6 weeks
To assess usage of device and batteries for each field trial period.
Frequency of battery replacement for each sound processor for each field trial.
Time frame: 2 weeks, 4 weeks and 6 weeks
This study is completed, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.
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