Combined Electric and Acoustic Hearing (EAS) in Children and Adults
A legfontosabb adatok
- Ki végzi
- Hearts for Hearing
- Hol
- Austin, Edmond, Madison és Nashville (Egyesült Államok)Mind a 4 helyszín megnézése
- Azonosító
- Állapot
- Toboroz
- Résztvevők
- 160 fő, tervezett
- Kezdés
- 2022. dec. 5.
- Várható befejezés
- 2028. aug. 31.
- A vizsgálat típusa
- Beavatkozással járó, 4 csoportAz egyik csoport nem kap vizsgálati kezelést, összehasonlításként.
- A vizsgált kezelések
- Electric and acoustic stimulation (EAS) technology in the implanted ear(s)-this is the combination of a cochlear implant (CI) and hearing aid (HA) in the implanted ear(s)
- A regiszteradat frissítve
- 2025. október 20.
Ki vehet részt
MI-összefoglaló
A vizsgálat saját részvételi feltételeiből. Gép olvasta ki az oldalon álló regiszterszövegből, ezért tévedhet. Hogy ki vehet részt, azt a lenti regiszterszöveg és a vizsgálat csapata dönti el.
The trial is looking for children and adults who use a cochlear implant (CI) and still have some low-pitch natural hearing in both ears. It is also looking for children and adults with normal hearing to compare with.
- Életkor
- 5 years and older. Children aged 5 to 17 years and adults aged 18+ years.
- Nem
- All sexes can join.
- A betegség stádiuma
- People with a CI need at least one CI and mild to severe sensorineural (inner ear) hearing loss in both ears. Without aids, hearing thresholds must be 80 dB HL or less at 125 and 250 Hz in both ears. People with normal hearing can also join.
- Korábbi kezelés
- People in the CI groups must already have at least 1 cochlear implant. They must be willing to use combined electric and acoustic hearing (EAS) in the implanted ear(s). This is checked with data from the device software.
A részvétel fő kizáró okai
- Deafness in one ear only (single-sided deafness) in CI participants
- Nonverbal intelligence standard score < 85
- Adults with a MoCA or HI-MoCA memory and thinking test score < 26
- Autism, auditory neuropathy, a neurological disorder or general cognitive impairment
A regiszter feltételei, szó szerint
Mind a 7 feltétel megnézéseKevesebb
Ki vehet részt
- Children aged 5 to 17 years of age with either normal hearing (n=40) or at least 1 cochlear implant (CI) and binaural low-frequency acoustic hearing (n=40); adults aged 18+ years with either normal hearing (n=40) or at least 1 CI and binaural low-frequency acoustic hearing (n=40)
- Experimental participants must have at least one CI and bilateral mild to severe sensorineural hearing loss For CI participants, audiometric thresholds in the non-CI ear must be consistent with at least a mild sensorineural hearing loss; that is, the investigators will not be enrolling participants with single-sided deafness (SSD) For CI participants, unaided audiometric thresholds must be less than or equal to 80 dB HL for 125 and 250 Hz, in both ears
- Nonverbal cognitive abilities within the typical range for all participants; adult participants must also pass cognitive screening via Montreal Cognitive Assessment (MoCA or HI-MoCA)
- No confounding diagnosis such as autism, auditory neuropathy, neurological disorder, or general cognitive impairment
- Willingness to use EAS technology in the implanted ear(s) to be verified via data logging from cochlear implant and hearing aid software
Ki nem vehet részt
- Nonverbal intelligence standard score < 85 (for any participant)
- MoCA or HI-MoCA score < 26 for adult participants
Helyszínek itt: Egyesült Államok
- University of Texas at AustinAustin, Egyesült ÁllamokContact: Spencer Smith, PhDRésztvevőt keres
- Hearts for HearingEdmond, Egyesült ÁllamokContact: René H Gifford, PhDRésztvevőt keres
- University of Wisconsin - MadisonMadison, Egyesült ÁllamokContact: Shelly GodarRésztvevőt keres
- Vanderbilt University Medical CenterNashville, Egyesült ÁllamokContact: René Gifford, PhDNo longer taking part
A vizsgálatról
Mit akar kideríteni a vizsgálat
Cochlear implants are surgically implanted devices which restore the ability to hear to the hearing impaired. Improvements in surgery and electrodes have results in an increased number of adults and children who have residual hearing and can benefit from electric and acoustic hearing in the same ear. This is called Electric Acoustic Stimulation (EAS). Many studies have shown that adult EAS users show significant benefits for speech understanding in noise and spatial hearing tasks as compared to a CI paired only with a contralateral HA. Even though this type of hearing is becoming more common, there is limited research on how it can be beneficial to children with CIs. The benefits of this study are a greater understanding of the participant's speech understanding, binaural processing, and spatial hearing. The results will help audiologists and researcher better understand how cochlear implants work, specifically when using electric and acoustic hearing in the same ear.
A vizsgálat 4 csoportja
- Adult use of EASA vizsgált kezelés
Clinical intervention; Adults with CI and the fitting of electric and acoustic stimulation (EAS) technology in the implanted ear(s).
Kezelés: Electric and acoustic stimulation (EAS) technology in the implanted ear(s)-this is the combination of a cochlear implant (CI) and hearing aid (HA) in the implanted ear(s)
- Pediatric use of EASA vizsgált kezelés
Clinical intervention; Children with CI and the fitting of electric and acoustic stimulation (EAS) technology in the implanted ear(s).
Kezelés: Electric and acoustic stimulation (EAS) technology in the implanted ear(s)-this is the combination of a cochlear implant (CI) and hearing aid (HA) in the implanted ear(s)
- Children with Normal HearingNincs vizsgálati kezelés, összehasonlításként
Children with normal hearing; acoustic only
- Adults with Normal HearingNincs vizsgálati kezelés, összehasonlításként
Adult with normal hearing; acoustic only
Kérdések a vizsgálat csapatának
- Milyen gyakran kell bejárnom, és egy-egy alkalom mennyi ideig tart?
- Megtérítik az utazási költséget?
- Megtarthatom a saját orvosomat?
- Mi történik, ha ki akarok lépni?
Contact the study team: see the registry record → Contacts and Locations
Oldal nyomtatása az orvosomnakAdatok és források
- Regiszteradat
- Szerepel a ClinicalTrials.gov-on.
- Hivatalos cím
- Binaural Cue Sensitivity in Children and Adults With Combined Electric and Acoustic Stimulation
- MI-összefoglaló
- A vizsgálat saját részvételi feltételeiből. Gépi kiolvasás: 2026. november 14.
- A regiszteradat frissítve
- 2025. október 20.