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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AAB | Active Comparator | Starts with Device A in first and second trial period and change to Device B in third trial period. |
|
| ABA | Active Comparator | Starts with Device A in first trial period, wears Device B in second trial period and change to Device A in third trial period. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Device A | Device | Participant wear Device A and evaluate the performance of the device. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 4 weeks or 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| To assess the preference of BAHS sound processor. | Percentage (%) of subjects who prefer Device A over Device B in noisy sound environments. | 6 weeks |
| To assess the improvement of hearing with Device A. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and week 4 or week 6 |
Inclusion Criteria:
Signed Informed Consent Form
Adult subjects (18 years or older)
Subjects using a Ponto 3 SuperPower on Oticon Medical compatible abutment
Experienced BAHS users with a minimum experience of 3 months.
Subjects with:
Fluent in Danish
Exclusion Criteria:
Subjects meeting any of the following criteria will not be permitted to participate in the investigation:
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| Name | Affiliation | Role |
|---|---|---|
| Mona El Hichou, MSc | Oticon Medical c/o Oticon A/S | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oticon Medical c/o Oticon A/S | Copenhagen | Smørum | 2765 | Denmark |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Nov 28, 2022 | |
| Reset | Oct 6, 2023 | |
| Release | Feb 18, 2025 | |
| Reset | Mar 11, 2025 | |
| Release | Mar 13, 2025 | |
| Reset | Apr 1, 2025 | |
| Release | Nov 17, 2025 | |
| Reset | Dec 1, 2025 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Nov 28, 2022 | Oct 6, 2023 | |||
| Feb 18, 2025 |
| ID | Term |
|---|---|
| D034381 | Hearing Loss |
| D006314 | Hearing Loss, Conductive |
| D046089 | Hearing Loss, Mixed Conductive-Sensorineural |
| D006311 | Hearing Disorders |
| D003638 | Deafness |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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The study includes four laboratory visits and three field trial periods. The first trial period is included to ensure a homogenous baseline. After the first trial period, the study is designed as a two-period, two-sequence crossover trial to compare 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.
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The participants are blinded to the tested conditions in the lab, used for assessment of the primary objective, but the participants are not blinded to the sound processors used during the three trial periods, due to different appearance of the sound processors, making it possible to distinguish between the sound processors.
| Device B | Device | Participant wear Device B and evaluate the performance of the device. |
|
| Baseline |
| To assess the degree to which Device A compensates for the BC hearing loss for the group CHL/MHL |
| 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). | 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. | 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. | 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. | 4 weeks or 6 weeks |
| To assess self-reported performance with Device A and Device B. |
| 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 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. | 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. | 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. | 1 week, 2 weeks, 4 weeks and 6 weeks |
| To list comments and reactions from the subjects with Device A and Device B. | Immediate reactions collected with each sound processor before field trial. | 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). | 2 weeks |
| To assess usage of device for each field trial period. | Average hours of usage of each sound processor for each field trial. | 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. | 2 weeks, 4 weeks and 6 weeks |
| Mar 11, 2025 |
| Mar 13, 2025 | Apr 1, 2025 |
| Nov 17, 2025 | Dec 1, 2025 |