Lumity CI Study - Clinical Evaluation of Next Generation Cochlear Implant Sound Processor
Evaluation of Advanced Bionics Next Generation CI Sound Processor Programmed With Target CI v.1.6 Fitting Software in Adult Users of the HiResolution™ Bionic Ear System
This is a prospective within-subjects repeated-measures study that will enroll 18 bilateral adult users implanted with a HiResolution Bionic Ear System (HiRes 90KTM, HiRes 90K TM Advantage, HiResTM Ultra, HiResTM Ultra 3D and CII with HiFocus electrode).
調査の概要
状態
詳細な説明
The overall goal of this clinical study is to demonstrate the safety and efficacy of next generation sound processor in users of the HiResolution Bionic Ear System. Speech understanding outcomes are expected to be similar with the new sound processor as compared to the Naída CI M90 processor. Therefore, the study uses a non-inferiority design to demonstrate non-inferiority of the next generation processor, relative to the currently approved Naída CI M90 for sentence understanding in quiet and in noise. Additionally, the features on the new device will be evaluated to demonstrate spatial situational awareness using a localization tasks.
研究の種類
入学 (実際)
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Ability to provide Informed Consent
- 18 years of age or older
- Bilateral users of a HiResolution™ Bionic Ear System (HiRes 90K™, HiRes 90K™ Advantage, HiRes™ Ultra, HiRes™ Ultra 3D and CII with HiFocus electrode)
- Willingness to participate in all scheduled procedures outlined in the study investigational plan
- Minimum of 6 months of CI experience for each ear
- At least moderate open-set speech recognition abilities with implant in each individual implanted ear, as defined by achieving a score of ≥ 50% words correct in the AzBio Sentence Test in quiet using a Naída CI M90 research processor
- English language proficiency, as determined by the investigator
- Willingness to use a behind-the-ear research processor for the duration of the study
Exclusion Criteria:
- Unrealistic expectations regarding potential benefits, risks and limitations of the investigational device as determined by the investigator
- Unwillingness or physical / cognitive inability of subject to comply with all investigational requirements as determined by the investigator
- < 50% words correct AzBio Sentence Test in quiet in either ear using the Naída CI M90 research processor
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Bilateral Users of a HiResolution Bionic Ear System
Control Device followed by experimental Device. |
Device: Naida M90 sound processor programmed with Target CI v1.5 software Device: Next generation sound processor programmed with investigation software |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Speech Recognition in Quiet
時間枠：1 Day
|
The primary objective is to demonstrate that speech recognition in quiet on a Next Generation CI sound processor is no worse than speech recognition in quiet on the currently approved Naída CI M90 processor for speech understanding in quiet. Scores are expressed as a percentage of words correct from 0% to 100% with higher scores indicating a better outcome. During the test the subject will be presented with a minimum of 133 words up to a maximum 159. |
1 Day
|
協力者と研究者
スポンサー
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。