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| Name | Class |
|---|---|
| Avania | INDUSTRY |
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The goal of this interventional study is to evaluate the clinical performance and sound quality of the Osia 3 Sound Processor and to demonstrate its superiority compared with the Osia 2 Sound Processor in adults with mixed hearing loss, conductive hearing loss, or single-sided deafness.
The main questions this study aims to answer are:
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cochlear™ Osia® 2 Sound Processor | Active Comparator | Participants randomized to group 1 will first receive a study Osia 2 Sound Processor to use at home for 1-2 weeks, before returning to the clinic to complete various assessments. These participants will then switch to the Osia 3 Sound Processor and complete the same protocol. |
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| Cochlear™ Osia® 3 Sound Processor | Experimental | Participants randomized to group 2 will first receive a Osia 3 Sound Processor to use at home for 1-2 weeks, before returning to the clinic to complete various assessments. These participants will then switch to the Osia 2 Sound Processor and complete the same protocol. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cochlear™ Osia® System (Osia® 2) | Device | Consists of Osia 2 Sound Processor, Osia 2 Sound Processor Magnets, and Osia Fitting Software 2. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean difference in speech reception threshold in noise with the Osia 3 Sound Processor, 1-2 weeks after fitting compared to the unaided condition at baseline | Speech perception in noise will be assessed using the Australian Speech Test in Noise (AuSTIN) at the Australian sites and the Bamford-Kowal-Bench Speech-In-Noise (BKB-SIN) test at the US site. The AuSTIN uses BKB-SIN like target sentences presented in noise and comprises of 80 lists of 20 sentences each. The BKB-SIN test contains 18 list pairs of sentences, each containing 3-4 key words, presented at 65 dB SPL with adaptive noise levels. Both tests aim to determine the signal-to-noise ratio (SNR) at which 50% of the key words are correctly repeated. For the unaided and aided measurements, speech performance in noise will be measured with speech and noise presented from a front speaker, positioned at 1 m from the subject. | At Baseline (Day 0), Visit 1 (7-14 days after Baseline), and Visit 2 (7-14 days after Visit 1) |
| Measure | Description | Time Frame |
|---|---|---|
| Mean difference in the word recognition score in quiet with the Osia 3 Sound Processor measured at 65 dB SPL, 1-2 weeks after fitting compared to the unaided condition at baseline | Speech perception in quiet will be measured using the consonant-nucleus-consonant (CNC) monosyllabic words presented at 65 dB SPL from the front speaker. The CNC word test consists of 30 lists each with 50 words per list. The goal of the speech perception assessment in quiet is to obtain the percentage of correctly repeated words in a list, i.e., the word recognition score. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| PRS Specialist | Cochlear Ltd | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cochlear Americas, Denver Research and Technology Lab | Denver | Colorado | 80124 | United States | ||
| Cochlear Macquarie, Macquarie University |
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The investigation uses a repeated-measures, cross-over design where study recipients will be randomized into one of two groups (1:1 ratio)
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| Cochlear™ Osia® System (Osia® 3) | Device | Consists of Osia 3 Sound Processor, Osia 3 Sound Processor Magnets, Osia 3 Charger, and Osia Fitting Software 3. |
|
| At Baseline (Day 0), Visit 1 (7-14 days after Baseline), and Visit 2 (7-14 days after Visit 1) |
| Mean difference in the four-frequency sound field threshold average (PTA4, mean of sound field thresholds at 0.5, 1, 2, and 4 kHz) with the Osia 3 Sound Processor, 1-2 weeks after fitting compared to the unaided condition at baseline | Thresholds in sound field will be measured using warble tones presented from a front speaker positioned at 1 m from the subject following the modified Hughson-Westlake procedure. Frequencies to be tested are 250, 500, 750, 1000, 1500, 2000, 3000, 4000, 6000, and 8000 Hz. | At Baseline (Day 0), Visit 1 (7-14 days after Baseline), and Visit 2 (7-14 days after Visit 1) |
| Mean difference in speech perception in noise with the Osia 3 Sound Processor compared with the Osia 2 Sound Processor measured at a fixed signal-to-noise ratio (SNR) of 0 dB SNR, 1-2 weeks after fitting | Speech perception in noise with a fixed SNR will be measured using the AzBio sentence test, which consists of 15 lists of 20 sentences each. AzBio sentences are spoken by different talkers in a conversational style with limited contextual cues that the listener can use to predict or 'fill in' unintelligible words. The sentences will be presented at a fixed level of 65 dB SPL at a fixed SNR of 0 dB SNR using the accompanying noise stimulus. Each word in the sentence counts towards the overall score (percent correct). Speech will be presented from the front, while noise will be presented from the rear. | At Visit 1 (7-14 days after Baseline) and Visit 2 (7-14 days after Visit 1) |
| Mean difference in speech perception in noise with the Osia 3 Sound Processor compared with the Osia 2 Sound Processor measured at a fixed signal-to-noise ratio (SNR) of +5 dB SNR, 1-2 weeks after fitting | Speech perception in noise with a fixed SNR will be measured using the AzBio sentence test, which consists of 15 lists of 20 sentences each. AzBio sentences are spoken by different talkers in a conversational style with limited contextual cues that the listener can use to predict or 'fill in' unintelligible words. The sentences will be presented at a fixed level of 65 dB SPL at a fixed SNR of +5 dB SNR using the accompanying noise stimulus. Each word in the sentence counts towards the overall score (percent correct). Speech will be presented from the front, while noise will be presented from the rear. | At Visit 1 (7-14 days after Baseline) and Visit 2 (7-14 days after Visit 1) |
| Mean difference in the Speech Spatial and Qualities of Hearing Scale (SSQ-12) global score with the Osia 3 Sound Processor compared with the Osia 2 Sound Processor, 1-2 weeks after fitting | The SSQ-12 involves a self-reported hearing function and the impact of hearing treatment in daily life across a variety of listening situations. It includes 3 subcategories: Speech Hearing, Spatial Hearing, and Qualities of Hearing, with each question rated on a Likert scale from 0-10 (minimum - maximum hearing abilities). | At Visit 1 (7-14 days after Baseline) and Visit 2 (7-14 days after Visit 1) |
| Mean difference in the word recognition score in quiet with the Osia 3 Sound Processor compared with the Osia 2 Sound Processor measured at 50 dB SPL, 1-2 weeks after fitting | Speech perception in quiet will be measured using the consonant-nucleus-consonant (CNC) monosyllabic words presented at 50 dB SPL from the front speaker. The CNC word test consists of 30 lists each with 50 words per list. The goal of the speech perception assessment in quiet is to obtain the percentage of correctly repeated words in a list, i.e., the word recognition score. | At Visit 1 (7-14 days after Baseline) and Visit 2 (7-14 days after Visit 1) |
| Mean difference in the word recognition score in quiet with the Osia 3 Sound Processor compared with the Osia 2 Sound Processor measured at 65 dB SPL, 1-2 weeks after fitting | Speech perception in quiet will be measured using the consonant-nucleus-consonant (CNC) monosyllabic words presented at 65 dB SPL from the front speaker. The CNC word test consists of 30 lists each with 50 words per list. The goal of the speech perception assessment in quiet is to obtain the percentage of correctly repeated words in a list, i.e., the word recognition score. | At Visit 1 (7-14 days after Baseline) and Visit 2 (7-14 days after Visit 1) |
| Mean difference in speech reception threshold in noise with the Osia 3 Sound Processor compared with the Osia 2 Sound Processor, 1-2 weeks after fitting | Speech perception in noise will be assessed using the Australian Speech Test in Noise (AuSTIN) at the Australian sites and the Bamford-Kowal-Bench-Speech in Noise (BKB-SIN) test at the US site. The AuSTIN uses BKB-SIN like target sentences presented in noise and comprises of 80 lists of 20 sentences each. The BKB-SIN test contains 18 list pairs of sentences, each containing 3-4 key words, presented at 65 dB SPL with adaptive noise levels. Both tests aim to determine the signal-to-noise ratio (SNR) at which 50% of the key words are correctly repeated. For the unaided and aided measurements, speech performance in noise will be measured with speech and noise presented from a front speaker, positioned at 1 m from the subject. | At Visit 1 (7-14 days after Baseline) and Visit 2 (7-14 days after Visit 1) |
| Mean difference in the four-frequency sound field threshold average (PTA4, mean of sound field thresholds at 0.5, 1, 2, and 4 kHz) with the Osia 3 Sound Processor compared to the Osia 2 Sound Processor, 1-2 weeks after fitting | Thresholds in sound field will be measured using warble tones presented from a front speaker positioned at 1 m from the subject following the modified Hughson-Westlake procedure. Frequencies to be tested are 250, 500, 750, 1000, 1500, 2000, 3000, 4000, 6000 and 8000 Hz. | At Visit 1 (7-14 days after Baseline) and Visit 2 (7-14 days after Visit 1) |
| Sydney |
| New South Wales |
| 2109 |
| Australia |
| HEARnet Clinical Studies | Melbourne | Victoria | 3010 | Australia |
| ID | Term |
|---|---|
| D046089 | Hearing Loss, Mixed Conductive-Sensorineural |
| D006314 | Hearing Loss, Conductive |
| ID | Term |
|---|---|
| D034381 | Hearing Loss |
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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