Utvärdering av flexibla ledande hörselhjälpmedel
En Icke-invasiv, Flexibel Ledande Hörselhjälpmedel Med Mikroepidermala Aktuatorer på Pediatriska och Vuxna Patienter
Conductive hearing loss (CHL) is the most common type of hearing loss among the pediatric population. CHL occurs when sound is not properly transmitted from the external ear to the cochlea, and congenital pathologies like microtia/anotia, atresia, and absent or malformed ossicles make hearing loss permanent.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
Standard treatment for permanent conductive hearing loss includes osseointegrated implants, which require surgery and are invasive for pediatric patients. Conductive hearing loss can also be treated by non-surgical solutions such as wearable and behind-the-ear aids; however, they present challenges such as instability, stigmatization, and discomfort because of the device's design. Therefore, patients (ages 6 months to 80 years) with permanent (CHL) can benefit from a flexible, Band-Aid like hearing aid.
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studiekontakt
- Namn: Mohammad Moghimi, PhD
- Telefonnummer: (336) 713-2113
- E-post: Seyyed.moghimi@wfusm.edu
Studera Kontakt Backup
- Namn: Enosh Lim, MS
- Telefonnummer: 704-355-2000
- E-post: Enosh.Lim@wfusm.edu
Studieorter
-
-
North Carolina
-
Winston-Salem, North Carolina, Förenta staterna, 27157
- Rekrytering
- Wake Forest University Health Sciences
-
Kontakt:
- Enosh Lim, MS
- Telefonnummer: 704-355-2000
- E-post: Enosh.Lim@wfusm.edu
-
Kontakt:
- Mohammad Moghimi, PhD
- Telefonnummer: 336-713-2113
- E-post: Seyyed.moghimi@wfusm.edu
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- Male and female infants, children, adolescents, and adult patients who are diagnosed with unilateral or bilateral mixed or conductive hearing loss
- Male and female patients seen at Atrium Health-Audiology for a clinical, standard of care office visit who have a diagnosis of conductive or mixed hearing loss and may currently wear hearing aids
- Male and female infants, children, adolescents, and adults who are candidates for conductive hearing aids (Osseo-integrated or wearable aids) or for canalplasty or ossicular chain reconstruction surgery
- Healthy subjects will include male and female infants, children, adolescents, and adults who do not have conductive or mixed hearing loss
- Pregnant women -are eligible for this study. Standard of Care allows pregnant patients to be fit for hearing aids without risk.
Exclusion Criteria:
- Adult patients unable to independently understand the purpose of the study and the procedures and/or who are not willing to participate
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Grundläggande vetenskap
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: flexible Band-Aid style hearing device
Patients with conductive/mixed hearing loss will be assessed to observe their hearing threshold before using the hearing aid and reassessed with our hearing aid attached. Healthy subjects will wear noise-cancelling headphones and ear plugs to simulate conductive hearing loss, and their hearing threshold will be assessed before and during the flexible hearing aid attachment. |
Eligible patients will wear hearing aids on flexible substrate and MEA (Micro epidermal actuator is a flexible material (e.g., plastics) to be placed on epidermis layer of skin for generating vibrations) on skull behind the ear or forehead. A neonatal adhesive, tape, Band-Aid or a headband will secure the aid/MEA on the skin. |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Does the subject indicate hearing or states they can hear sound
Tidsram: Hour 1
|
Voltage (with a maximum of 20 V, frequency range: 20 Hz to 20 kHz) will be applied to Micro epidermal actuator (MEA) through external power supply/function generator, or through amplifier in the hearing aid circuit. While wearing the device, they are asked to respond or repeat when they hear sound either delivered through the device or through the speaker on the wall in front of them. All sounds are presented at a comfortable level. |
Hour 1
|
Samarbetspartners och utredare
Utredare
- Huvudutredare: Mohammad Moghimi, PhD, Wake Forest University Health Sciences
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- IRB00133858
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
IPD-planbeskrivning
All of the individual participants data, collected during the trial after deidentification
Tidsram för IPD-delning
Immediately after publication. No end date
Kriterier för IPD Sharing Access
Any purposes
IPD-delning som stöder informationstyp
- STUDY_PROTOCOL
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