Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Avania | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Acceptance and performance of the CP1170 sound processor in experienced adult cochlear implant recipients compared with the CP1150 sound processor and their current sound processor.
This investigation is planned to investigate the performance and clinical benefits of features that are new to the CP1170 Sound Processor. This study will build on the evidence previously collected on off-the-ear (OTE) sound processors and ForwardFocus, with particular focus on the acceptance and satisfaction of the automation of ForwardFocus in the CP1170 Sound Processor and associated components in general.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CP1170 Sound Processor | Experimental | Take home use of CP1170 Sound Processor for 2 weeks followed by in-booth testing of this investigational device. The SCAN 2 FF (automated ForwardFocus On) program will be compared to the SCAN 2 (ForwardFocus Off) program in the CP1170 Sound Processor. This investigational device will also be compared to the CP1150 Sound Processor and participants' own sound processor. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CP1170 Sound Processor | Device | The CP1170 Sound Processor will be used to determine the hearing performance with the new implementation of ForwardFocus in SCAN 2 (SCAN 2 FF), as assessed by speech perception in noise. |
| Measure | Description | Time Frame |
|---|---|---|
| Paired Difference in dB SRT Between the CP1170 SCAN 2 FF (Automated ForwardFocus ON) and CP1170 SCAN 2 (ForwardFocus OFF) in 65 dB SPL (Sound Pressure Level) S0Nrearhalf 4Talker Babble (Speech Perception in Noise) | Speech perception in noise was measured using the Australian Speech Test In Noise (AUSTIN), which is a test that uses Bamford-Kowal-Bench (BKB)-like target sentences presented in adaptive noise. The goal of the speech perception test in noise was to provide the speech-to-noise ratio for 50% speech intelligibility. | During a Single Ad-Hoc Visit (between Day 141 - Day 218) |
| Measure | Description | Time Frame |
|---|---|---|
| Paired Difference in dB SRT Between the CP1170 SCAN 2 FF (Automated ForwardFocus ON) and CP1170 SCAN 2 (ForwardFocus OFF) in 65 dB SPL S0N3 Babble (Speech Perception in Noise) | Speech perception in noise was measured using the Australian Speech Test In Noise (AUSTIN), which is a test that uses Bamford-Kowal-Bench (BKB)-like target sentences presented in adaptive noise. The goal of the speech perception test in noise was to provide the speech-to-noise ratio for 50% speech intelligibility. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cochlear Macquarie | Macquarie | Sydney | 2109 | Australia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41884522 | Derived | Jones M, Hong W, Schou IM, Mashal ME. Improved Speech Recognition with Automated ForwardFocus in Cochlear Kanso 3 Sound Processor Users. Otol Neurotol Open. 2026 Mar 18;6(1):e087. doi: 10.1097/ONO.0000000000000087. eCollection 2026 Mar. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Adults With a Cochlear Implant | All study participants (post-lingually deafened adults with at least 6 months experience with a cochlear implant and 3 months experience with SCAN program). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Adults With a Cochlear Implant | All study participants (post-lingually deafened adults with at least 6 months experience with a cochlear implant and 3 months experience with SCAN program). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Paired Difference in dB SRT Between the CP1170 SCAN 2 FF (Automated ForwardFocus ON) and CP1170 SCAN 2 (ForwardFocus OFF) in 65 dB SPL (Sound Pressure Level) S0Nrearhalf 4Talker Babble (Speech Perception in Noise) | Speech perception in noise was measured using the Australian Speech Test In Noise (AUSTIN), which is a test that uses Bamford-Kowal-Bench (BKB)-like target sentences presented in adaptive noise. The goal of the speech perception test in noise was to provide the speech-to-noise ratio for 50% speech intelligibility. | Posted | Mean | 95% Confidence Interval | dB SRT | During a Single Ad-Hoc Visit (between Day 141 - Day 218) |
|
12 months
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Adults With a Cochlear Implant | All study participants (post-lingually deafened adults with at least 6 months experience with a cochlear implant and 3 months experience with SCAN program). |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ear-related adverse event | Ear and labyrinth disorders | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| PRS Specialist, Clinical Affairs | Cochlear | +61 2 9428 6555 | cltd-prs-admin@cochlear.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 4, 2023 | Jun 17, 2025 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D034381 | Hearing Loss |
| ID | Term |
|---|---|
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D012678 | Sensation Disorders |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| CP1150 Sound Processor | Device | Active comparator off-the-ear sound processor. |
|
| During a single Ad-Hoc Visit (anytime between Day 141 - Day 218) |
| Paired Difference in Percentage CNC (Consonant-nucleus-consonant) Words Correct in Quiet (50 dB) Between the CP1170 Sound Processor and CP1150 Sound Processor (Commercial Version) | Speech perception in quiet was measured using the CNC monosyllabic words at 50 dB SPL from S0 position. The goal of speech perception assessment in quiet was to compare % words correct for each of the conditions. | During Ad-Hoc Visit (anytime between Day 127 - Day 190) |
| Subjective Acceptance and Satisfaction Between the CP1170 Sound Processor and the Subject's Own Processor | Number of participants who were somewhat or very satisfied with the overall sound quality of their SCAN program (SCAN in own sound processor, SCAN 2 FF in CP1170) as indicated through two questionnaires. The CP1170 Questionnaire and Baseline Questionnaire have a 5-point Likert scale for each rating (with the values ranging from: 1 = least favourable option to 3 = Neutral to 5 = most favourable option). | 2 weeks |
| Paired Difference in Global SSQ12 Scores After Experience With the CP1170 Sound Processor and Own Processor | The SSQ12, which measures subjective hearing performance, is comprised of 12 items using the response format on a scale from 0 to 10, where 0 equals no ability and 10 equals perfect ability. These are divided into three sub-scales and the questions 1-5 are from the speech sub-scale, 6-8 from the spatial, and 9-12 from the qualities sub-scale. The three sub-scales are the average of the questions within. A 'not applicable' option is given for each item. The change from baseline is then calculated and the theoretical score could vary between -10 to +10. The higher the score, the higher the benefit. A positive score indicates improved hearing, and a negative value indicates impaired hearing. | During a Single Ad-Hoc Visit (anytime between Day 23 - Day 70) |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Paired Difference in dB SRT Between the CP1170 SCAN 2 FF (Automated ForwardFocus ON) and CP1170 SCAN 2 (ForwardFocus OFF) in 65 dB SPL S0N3 Babble (Speech Perception in Noise) | Speech perception in noise was measured using the Australian Speech Test In Noise (AUSTIN), which is a test that uses Bamford-Kowal-Bench (BKB)-like target sentences presented in adaptive noise. The goal of the speech perception test in noise was to provide the speech-to-noise ratio for 50% speech intelligibility. | Posted | Mean | 95% Confidence Interval | dB SRT | During a single Ad-Hoc Visit (anytime between Day 141 - Day 218) |
|
|
|
| Secondary | Paired Difference in Percentage CNC (Consonant-nucleus-consonant) Words Correct in Quiet (50 dB) Between the CP1170 Sound Processor and CP1150 Sound Processor (Commercial Version) | Speech perception in quiet was measured using the CNC monosyllabic words at 50 dB SPL from S0 position. The goal of speech perception assessment in quiet was to compare % words correct for each of the conditions. | Posted | Mean | 95% Confidence Interval | Percentage of correct words | During Ad-Hoc Visit (anytime between Day 127 - Day 190) |
|
|
|
| Secondary | Subjective Acceptance and Satisfaction Between the CP1170 Sound Processor and the Subject's Own Processor | Number of participants who were somewhat or very satisfied with the overall sound quality of their SCAN program (SCAN in own sound processor, SCAN 2 FF in CP1170) as indicated through two questionnaires. The CP1170 Questionnaire and Baseline Questionnaire have a 5-point Likert scale for each rating (with the values ranging from: 1 = least favourable option to 3 = Neutral to 5 = most favourable option). | At baseline, 20 participants completed the Baseline Questionnaire. As three participants did not complete the study, the CP1170 Questionnaire was completed by 17 participants rather than 20. | Posted | Count of Participants | Participants | 2 weeks |
|
|
|
| Secondary | Paired Difference in Global SSQ12 Scores After Experience With the CP1170 Sound Processor and Own Processor | The SSQ12, which measures subjective hearing performance, is comprised of 12 items using the response format on a scale from 0 to 10, where 0 equals no ability and 10 equals perfect ability. These are divided into three sub-scales and the questions 1-5 are from the speech sub-scale, 6-8 from the spatial, and 9-12 from the qualities sub-scale. The three sub-scales are the average of the questions within. A 'not applicable' option is given for each item. The change from baseline is then calculated and the theoretical score could vary between -10 to +10. The higher the score, the higher the benefit. A positive score indicates improved hearing, and a negative value indicates impaired hearing. | Twenty participants completed the SSQ12 at Baseline for their own sound processor, however, due to subject attrition, only 18 participants completed the questionnaire on the CP1170 Sound Processor. | Posted | Mean | 95% Confidence Interval | SSQ12 Global score | During a Single Ad-Hoc Visit (anytime between Day 23 - Day 70) |
|
|
|
| 0 |
| 20 |
| 0 |
| 20 |
| 7 |
| 20 |
| Non ear-related | Gastrointestinal disorders | Non-systematic Assessment | Gastrointestinal problem |
|
Not provided
Not provided
Not provided
| D009461 |
| Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
|
|
|
|
| Difference between CP1170 and own sound processor |
|
|