[c09aa8]: / clusters / clusters342final / clust_236.txt

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No signs of clinically significant hearing loss
Vision and hearing (eyeglasses and/or hearing aid permissible) sufficient for valid test administration and cooperation with examinations
Patients must have a pure tone audiometry evaluation to document air conduction within 30 days prior to registration; patients with hearing loss > 40 dB in any of the five tested frequencies (250 Hertz [Hz], 500 Hz, 1,000 Hz, 2,000 Hz, 4,000 Hz) are not eligible; patients with active ear infections should be tested only after the acute phase of infection has resolved; for optimal results, it is recommended that testing be conducted by an audiologist, in a hearing test room, with insert earphones; Note: sites should not order audiometry evaluation until the potential participant has met all other eligibility criteria required for this study
Significant pre-existing hearing loss, as defined by the patient or treating physician
Patients with hearing loss assessed to be primarily sensorineural in nature, requiring a hearing aid, or intervention (i.e. interfering in a clinically significant way with activities of daily living); a conductive hearing loss from tumor-related otitis media is allowed
Patients must not have a clinically relevant hearing impairment > grade 2
Hearing loss that would preclude participating in interventions; adequate hearing to participate will be determined via: (1) response of no to the question [Do you have a hearing problem now?]; participants with hearing aids will be allowed to enroll as long as their hearing is adequate to hear the sounds on the study devices; if necessary, potential study participants will receive a brief test trial with the RESPeRATE device; if they indicate inability to hear the guiding tones, they will not be enrolled in the study
Patients must not have a clinically relevant hearing impairment >= grade 2
Has experienced prior or ongoing hearing impairment due to chemotherapy or radiotherapy as defined by one of the following: * Society of Pediatric Oncology (SIOP) grade 1 hearing loss* Subjective (patient-reported) hearing difficulties* Subjective (patient-reported) tinnitus