Evaluation of the Clinical Benefit of a Transmitter for Contralateral Routing of Signals (CROS)
Przegląd badań
Status
Warunki
Interwencja / Leczenie
Szczegółowy opis
Unilateral Hearing Loss (UHL) can be defined as any degree of permanent hearing loss on one ear with normal hearing in the opposite ear. Unilateral hearing loss can be debilitating associated with audiological, psychosocial and educational challenges. Audiological challenges include the reduced ability to localize sounds, reduced awareness on the unaidable side and difficulties hearing in noise or at a distance.
One solution for unaidable UHL is Contralateral Routing of Signals (CROS) and Bilateral Contralateral routing of signals (BiCROS) using a so- called CROS transmitter together with a hearing aid.
The rationale for this clinical investigation is to collect clinical data with a rechargeable CROS transmitter to evaluate the benefits of a BiCROS fitting compared to the alternative treatment option, the monaural hearing aid fitting, and to no treatment in noisy listening situations.
Typ studiów
Zapisy (Rzeczywisty)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Lokalizacje studiów
-
-
Zürich
-
Stäfa, Zürich, Szwajcaria, 8712
- Sonova AG
-
-
Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
Inclusion Criteria:
- hearing impaired adults, with & w/o hearing aids (experiences)
- good written and spoken (Swiss) German language skills
- ability to fill in a questionnaire conscientiously
- informed consent as documented by signature
- asymmetric hearing loss: one unaidable ear (min. N6 hearing loss) / the other ear with N3 or N4 hearing loss
- availability of Smartphone
- availability of TV or Tablet
- ability to operate and handle the investigational device
- ability to describe listening impressions/experiences and the use of the hearing aid
- Ability to produce a reliable hearing test result
Exclusion Criteria:
- Contraindications to the medical device:
- aidable hearing loss on the intended CROS side
- acute tinnitus (in either one ear and occurrence less than three months)
- anatomical deformity of the CROS ear (e.g. absence of the auricle)
- Known hypersensitivity or allergy to materials of the investigational device
- any auricle deformities, that prevents secure placement of the (test) devices
- no willingness to test the investigational device system
- no willingness to test the investigational device system for at least 8h a day
- Hint for psychological problems from investigators point of view
- reported fluctuating hearing that could influence the test result
- reported symptoms of vertigo and dizziness by participants
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Inny
- Przydział: Nie dotyczy
- Model interwencyjny: Zadanie dla jednej grupy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
|
Eksperymentalny: Speech Intelligibility with CROS device
The focus of this study is on Speech Intelligibility (SI), evaluated by the Oldenburg Sentence test (OLSA), which measures a speech recognition threshold (SRT) in dB SNR (signal to noise ratio). Therefore each participant will perform the tests with the experimental rechargeable CROS transmitter (CROS) in different interventions, like comparison to monaural fitting and unaided condition. All participants will perform the same tests. The order of the intervention in the speech test is randomized, but will be performed in the same visit by each participant. |
Brak leczenia, tj. uczestnicy nie są wyposażeni w urządzenie CROS i/lub aparat słuchowy. Stan bez pomocy działa jako interwencja kontrolna.
Each participant will be fitted with the experimental CROS device on the poorer, unaidable ear and with a compatible hearing device on the other ear.
Each participant will be fitted with a hearing aid on the better hearing ear and no device on the poorer, unaidable ear. Monaural hearing aid fitting acts as control intervention. Each participant will be fitted with the experimental CROS device on the poorer, unaidable ear and with a compatible device on the other ear. The difference to the BiCROS condition is the setup of the microphones in the CROS device and the compatible hearing device. This test condition is only tested for speech intelligibility in diffuse noise and acts as control intervention. |
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Speech Intelligibility (SI) in noise (fix direction): BiCROS fitting vs. monaural hearing aid fitting
Ramy czasowe: 2 weeks
|
The primary objective of this clinical investigation is to evaluate whether a BiCROS fitting (better ear fitted with a hearing device, unaidable ear supplied with a CROS device) improves speech intelligibility in noise compared to a monaural fitting (just the aidable ear is supplied by a hearing aid), for adults with an asymmetric hearing loss, measured with the Oldenburg Sentence Test (OLSA). Results of the speech test will be the SRT (speech recognition threshold) in dB SNR (signal to noise ratio). The target speaker will be presented from 0° azimuth and is adaptive (start level at 65dB (A). The noise will be presented on the better ear at an azimuth of 90° or 270° (depending on the site of the better ear), at a level of 70 dB (A). |
2 weeks
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
SI in noise (fix direction): BiCROS fitting vs. unaided
Ramy czasowe: 2 week
|
A secondary objective of this clinical investigation is to evaluate whether a BiCROS fitting improves speech intelligibility in noise compared to an unaided condition, for adults with an asymmetric hearing loss, measured with the Oldenburg Sentence Test (OLSA). Results of the speech test will be the SRT (dB SNR). The target speaker will be presented from 0° azimuth and is adaptive (start level at 65dB (A). The noise will be presented on the better ear at an azimuth of 90° or 270° (depending on the site of the better ear), at a level of 70 dB (A). |
2 week
|
|
SI in diffuse noise: BiCROS fitting vs. monaural fitting
Ramy czasowe: 2 weeks
|
A secondary objective of this clinical investigation is to evaluate whether a BiCROS fitting improves speech intelligibility by at least 1 dB SNR for 50% SRT in diffuse noise, compared to a monaural hearing aid fitting. The target speaker will be presented from 0° azimuth and is adaptive (start level at 65dB (A). The noise will be presented on the better ear at an azimuth of 90° or 270° (depending on the site of the better ear), at a level of 70 dB (A). |
2 weeks
|
|
SI in diffuse noise: BiCROS fitting vs. unaided
Ramy czasowe: 2 weeks
|
A secondary objective of this clinical investigation is to evaluate whether a BiCROS fitting improves speech intelligibility by at least 1 dB SNR for 50% SRT in diffuse noise, compared to an unaided condition. The target speaker will be presented from 0° azimuth and is adaptive (start level at 65dB (A). The noise will be presented on the better ear at an azimuth of 90° or 270° (depending on the site of the better ear), at a level of 70 dB (A). |
2 weeks
|
|
SI in diffuse noise: BiCROS vs. CROS baseline fitting
Ramy czasowe: 2 weeks
|
A secondary objective of this clinical investigation is to evaluate whether a BiCROS fitting improves speech intelligibility in diffuse noise compared with a CROS baseline fitting. CROS baseline means a fitting of an additional program with different hearing instrument microphone setup. The SI will be tested with the OLSA in diffuse noise. The target speaker will be presented from 0° azimuth and is adaptive (start level at 65dB (A). The noise will be presented on the better ear at an azimuth of 90° or 270° (depending on the site of the better ear), at a level of 70 dB (A). |
2 weeks
|
|
SI in diffuse noise: CROS baseline fitting vs. unaided
Ramy czasowe: 2 weeks
|
A secondary objective of this clinical investigation is to evaluate whether a CROS baseline fitting improves speech intelligibility in diffuse noise compared with an unaided condition. The SI will be tested with the OLSA in diffuse noise. The target speaker will be presented from 0° azimuth and is adaptive (start level at 65dB (A). The noise will be presented on the better ear at an azimuth of 90° or 270° (depending on the site of the better ear), at a level of 70 dB (A). |
2 weeks
|
|
SI in diffuse noise: CROS baseline fitting vs. monaural fitting
Ramy czasowe: 2 weeks
|
A secondary objective of this clinical investigation is to evaluate whether a CROS baseline fitting improves speech intelligibility in diffuse noise compared with a monaural fitting. The SI will be tested with the OLSA in diffuse noise. The target speaker will be presented from 0° azimuth and is adaptive (start level at 65dB (A). The noise will be presented on the better ear at an azimuth of 90° or 270° (depending on the site of the better ear), at a level of 70 dB (A). |
2 weeks
|
|
SP in diffuse noise: monaural fitting vs. unaided
Ramy czasowe: 2 weeks
|
A secondary objective of this clinical investigation is to evaluate whether a monaural fitting improves speech intelligibility in diffuse noise compared with an unaided condition. The SI will be tested with the OLSA in diffuse noise. The target speaker will be presented from 0° azimuth and is adaptive (start level at 65dB (A). The noise will be presented on the better ear at an azimuth of 90° or 270° (depending on the site of the better ear), at a level of 70 dB (A). |
2 weeks
|
|
Evaluation of Sound quality
Ramy czasowe: 3 weeks
|
A secondary objective of this study is to evaluate the participant's satisfaction of the sound quality of the experimental CROS device by a subjective rating during a three-week home trial period. Scale: very unsatisfied- unsatisfied- neither nor- satisfied- very satisfied |
3 weeks
|
|
Evaluation of System stability
Ramy czasowe: 3 weeks
|
A secondary objective of this study is to evaluate the participant's satisfaction of the system stability of the experimental CROS device during a three-week home trial period. The participant shall report, if there are artefacts audible: never/ 1-2 times a week/ 3-6 times a week/ daily |
3 weeks
|
|
Evaluation of streaming
Ramy czasowe: 3 weeks
|
A secondary objective of this study is to evaluate the participant's satisfaction of the streaming sound quality of the experimental CROS device, by a subjective rating during a three-week home trial period. Scale: very unsatisfied- unsatisfied- neither nor- satisfied- very satisfied |
3 weeks
|
|
Evaluation of listening effort
Ramy czasowe: 3 weeks
|
A secondary objective is to evaluate the subjective listening effort in noise reported by the participant whilst wearing the experimental CROS device. Scale: not at all - slightly - somewhat - moderately - very - extremely |
3 weeks
|
Współpracownicy i badacze
Sponsor
Publikacje i pomocne linki
Publikacje ogólne
- Bagatto M, DesGeorges J, King A, Kitterick P, Laurnagaray D, Lewis D, Roush P, Sladen DP, Tharpe AM. Consensus practice parameter: audiological assessment and management of unilateral hearing loss in children. Int J Audiol. 2019 Dec;58(12):805-815. doi: 10.1080/14992027.2019.1654620. Epub 2019 Sep 5.
- Snapp HA, Hoffer ME, Spahr A, Rajguru S. Application of Wireless Contralateral Routing of Signal Technology in Unilateral Cochlear Implant Users with Bilateral Profound Hearing Loss. J Am Acad Audiol. 2019 Jul/Aug;30(7):579-589. doi: 10.3766/jaaa.17121. Epub 2018 Dec 13.
- Snapp H. Nonsurgical Management of Single-Sided Deafness: Contralateral Routing of Signal. J Neurol Surg B Skull Base. 2019 Apr;80(2):132-138. doi: 10.1055/s-0039-1677687. Epub 2019 Jan 17.
- Lieu JE, Tye-Murray N, Karzon RK, Piccirillo JF. Unilateral hearing loss is associated with worse speech-language scores in children. Pediatrics. 2010 Jun;125(6):e1348-55. doi: 10.1542/peds.2009-2448. Epub 2010 May 10.
- McKay S, Gravel JS, Tharpe AM. Amplification considerations for children with minimal or mild bilateral hearing loss and unilateral hearing loss. Trends Amplif. 2008 Mar;12(1):43-54. doi: 10.1177/1084713807313570.
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Rzeczywisty)
Ukończenie studiów (Rzeczywisty)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- SRF-377
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .