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Use of Amplification in Children With Unilateral Hearing Loss

Use of Amplification in Children With Unilateral Hearing Loss

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02269124
Acronym
UHL
Enrollment
37
Registered
2014-10-20
Start date
2014-10-01
Completion date
2020-03-16
Last updated
2021-08-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Unilateral Hearing Loss

Brief summary

Unilateral hearing loss (UHL) in children has been demonstrated to have a negative impact on quality of life, school performance and behavior. Despite this knowledge, it remains unclear how to best manage this common problem. There has been much debate regarding this issue with many programs recommending preferential seating in the classroom and use of a frequency-modulated (FM) system to amplify the teacher's voice in the classroom (conventional measures), and others recommending these accommodations in addition to use of a hearing aid for amplification (amplification). There is very limited research to support or refute the efficacy of a hearing aid in improving measurable academic, behavioral, or quality-of-life (QOL) outcomes in children with UHL. We propose a study evaluating the impact of hearing aid use in school-aged children (ages 6-12 years) with mild to moderately severe UHL. In this study, subjects will be randomized to receive either conventional measures or conventional measures plus amplification. After a three month period, the groups will be reversed, with each subject serving as their own control. Outcome measurements will include patient reported disease-specific QOL reported by patients, parents, and teachers using validated survey instruments at regular intervals throughout the study period.

Detailed description

Unilateral hearing loss (UHL) is defined as decreased hearing in one ear, with normal hearing thresholds in the contralateral ear. Approximately 0.83/1000 newborn children are found to have UHL. It is estimated that about 3-5% of all children in the United States are eventually diagnosed with UHL. When the cutoff for normal hearing is placed at 15 decibels (dB), this incidence is as high as 6.3%, which corresponds to a prevalence of 6.2 million children nationally. The management of UHL continues to be an area of debate, as the handicap associated with UHL is often underestimated. In fact, those with UHL often go without assistance due to lack of recognition of the disability by some health and educational professionals, who have claimed that this hearing loss attracts little attention from either patient or parent and that these children experience few communicational or educational problems. However, in evaluation of children with permanent hearing loss, rates of children who need speech/language intervention and aural rehabilitation are not significantly different between those with bilateral permanent hearing loss and those with unilateral permanent hearing loss. Unfortunately, children with UHL are half as likely to be referred for hearing testing as those with bilateral hearing loss. Studies have demonstrated the negative impact of unilateral hearing impairment in children. Educational and behavioral difficulties have been clearly shown, with a number of studies demonstrating increased rates of failure of at least one grade in children with UHL when compared to their classmates with normal hearing (24-35% vs. 3.5%). Additionally, increase in special educational needs (12-41%) and frequent problems with behavior have also been noted in this population. In several studies, Lieu and colleagues have shown poorer performance for children with UHL. In a study looking at oral and written language scores, children with UHL did significantly worse than their siblings, who served as matched controls, on language comprehension, oral expression, and oral composite scores. In addition, these children were four times more likely to have Individualized Education Plans (IEPs) and twice as likely to have received speech-language therapy. Despite these findings regarding the impact of UHL on children, there is a paucity of literature to support or refute the efficacy of hearing aid use in improving measurable academic, behavioral, or quality-of-life (QOL) outcomes. While hearing related disease-specific quality of life measures for children were not developed until very recently, previous studies in adults with UHL reported decreased quality of life, with increased frustration and shame due to hearing disability. The Hearing Environments and Reflection on Quality of Life questionnaire, or HEAR-QL, an instrument developed and validated at Washington University in St. Louis for young children with hearing loss initially (2011) and then later for adolescents (2013), examined effects on environments, activities, and feelings of children with both unilateral and bilateral hearing loss. Significantly lower scores, indicating poorer quality of life, were seen in patients with both UHL and bilateral hearing loss. Interestingly, differences in quality of life between children with UHL and children with bilateral hearing loss were found to be significant in only 1 out of 3 subdomains. A 2010 study by Johnstone et al. demonstrated that children with UHL who used amplification at a young age (6-9 years) had improvement in localization acuity, while those who received amplification at an older age (10-14 years) noted impairment in localization. This may indicate that the timing of initiation of amplification in UHL may play an important role in whether the intervention is beneficial. In addition, Noh and Park's study in 2012 demonstrated that children with UHL needed to sit 3.5 meters closer to the teacher to obtain the same speech discrimination scores as children with binaural hearing. While this can be accomplished in a small room setting, this may not be possible at all times in all classes, and it is certainly not translatable to hearing environments outside of the classroom. It is not clear whether adding amplification to would eliminate this handicap and improve quality of life, behavior, or academic performance. Current interventions: Multiple options exist for management of UHL. Preferential seating in the classroom is often the first line of treatment utilized, placing the child at the front of the classroom with the better hearing ear toward the teacher. Evaluation of the classroom by an educational audiologist or other specialist in the education of children with hearing loss in order to optimize the listening environment is another commonly utilized modality for managing UHL. Interventions such as carpeting, tennis balls placed on the legs of chairs, and selection of a classroom with lower ambient noise levels from outside traffic or air handling equipment can reduce significantly improve signal to noise ratios for the student. Another modality for improving signal to noise ration is use of a frequency-modulated (FM) system in the classroom, which specifically amplifies the teacher's voice via a microphone worn by the teacher. This increases the signal-to-noise ratio for the teacher's voice as it does not amplify background noise. Differentiating relevant sound signals from background noise a particularly challenging problem for children with UHL. Other options for management of UHL include various forms of amplification including a unilateral hearing aid, contralateral routing of sound (CROS) systems, and potentially cochlear implantation (though this practice has not been widely adopted in children with UHL in the United States). In the only study to date comparing the above modalities to one another, Updike compared speech perception measures in 6 children, ages 5 to 12 years, with mild to profound UHL with use of FM systems, CROS aids, and conventional hearing aids. He concluded that FM systems were beneficial in all hearing situations and in all degrees of hearing loss. In addition, he stated that neither hearing aids nor CROS aids provided benefit in speech understanding, and both may worsen speech perception in noisy situations. Multiple limitations exist with this study, including a small sample size and lack of a time period for the patients to adjust to the use of amplification. In studies looking at acceptance of hearing aid use in children with UHL, children with mild to moderately severe hearing loss tended to accept hearing aids, while those with severe to profound hearing loss were less accepting. Parental satisfaction with hearing aids in this population has been good, with many noticing improved hearing for their children. More recently, Briggs et al. published a study looking at 8 children, ages 7 to 12 years, with mild to moderately severe UHL, who were aided with digital hearing aids. Although speech perception scores did not show significant improvement, parents subjectively reported significant improvement in quality of life after 3 months of use. In one German study of 3 children with severe to profound unilateral hearing loss, improvement in speech understanding in noise and sound localization following cochlear implantation was observed and subjective improvement was reported by parents. Compliance with use of amplification should also be considered in these cases, as Fitzpatrick et al. demonstrated in a study of 670 children with unilateral or bilateral hearing loss. While amplification was recommended in 90%, less than two-thirds of the children wore their hearing aids consistently. To date, only two studies exist which examine the use of amplification in children with unilateral hearing loss. Both studies are limited by small sample size. In addition, the earlier study evaluated analog hearing aids, whereas in the present day, digital hearing aids are widely used, and was further limited by a very short study period. Our study proposes to examine whether children with UHL note improved quality of life when using amplification via a hearing aid in conjunction with conventional classroom accommodations including an FM system. In our study we will compare the use of conventional measures to conventional measures plus a digital hearing aid on the affected ear using validated quality of life instruments administered to the subject, the subject's teacher, and the subject's parent. The instruments used will be the HEAR-QL, the CHILD, and the LIFE-R (See outcome measures for details). Each of the surveys will be administered five times in total: at the time of enrollment, once at the midpoint of the first treatment arm, once after completion of the first treatment arm, once at the midpoint of the second treatment arm, and once after completion of the second treatment arm. Comparisons will then be made among groups as described later in this proposal. Our practice is well suited to carrying out this study as we are a tertiary care center serving a large region. Our multidisciplinary pediatric hearing loss clinic allows children to be evaluated and longitudinally followed in conjunction with the audiology, speech and language pathology, neuropsychology, and medical genetics. In the past year, there were over 300 visits coded for unilateral hearing loss based on ICD-9 codes, with 70 unique patients, making recruitment of our target sample size over the 3-year study period feasible. The potential impact of this study is great, as there is no consensus as to whether amplification should be recommended for children with unilateral hearing loss, and a study of this power would serve as a useful guide in this decision-making process.

Interventions

DEVICEHearing aid

The subject will wear a hearing aid at all times for a 3-month period. At school, he/she will wear this hearing aid in addition to using conventional measures (FM system and preferential seating).

Sponsors

Massachusetts Eye and Ear Infirmary
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
6 Years to 12 Years
Healthy volunteers
No

Inclusion criteria

Children ages 6-12 years with mild to moderately severe unilateral hearing loss, with thresholds across 4 frequencies ≥ 25 dB but \< 70 dB in the worse hearing ear; Normal hearing in the contralateral ear, defined as thresholds ≤ 20 dB from 250 Hz to 8000 Hz; Unaided word recognition scores of ≥ 80% in worse hearing ear

Exclusion criteria

Contralateral hearing loss; Significant cognitive impairment; Middle ear disease that has not been addressed; Inability to commit to treatment program

Design outcomes

Primary

MeasureTime frameDescription
HEAR-QL 26 Questionnaire6 monthsThe HEAR-QL consists of 28 items that measure the perceived effect of hearing loss on quality of life. It is adjusted to a scale of 0-100, with lower scores indicating a worse disease-specific quality of life and higher scores signifying a better disease-specific quality of life. The HEAER-QL-26 was one of three surveys used to evaluate the study's primary endpoint: subject-reported quality of life.
CHILD (Child) Questionnaires6 monthsThe CHILD (child) questionnaire consists of 15 questions that describe situations where hearing difficulty may occur when the child is with his/her family. The answers are measured on a scale of 1-8, with 1 indicating poor ability to hear, and 8 indicating complete understanding. The total scores across all questions were standardized on a scale of 0 to 100, with lower scores indicating a worse disease-specific quality of life and higher scores signifying a better disease-specific quality of life. Two versions, the CHILD (child) and the CHILD (parent) are phrased to apply to the child and the parent respectively. The CHILD (child) was one of three surveys used to evaluate the study's primary endpoint: subject-reported quality of life.
LIFE-R Student Questionnaires6 monthsThe LIFE-R Student questionnaire consists of 15 questions that describe situations where hearing difficulty may occur in school. The answers are measured on a scale of 1-5, with 1 indicating situations in which hearing is always difficult and 5 indicating situations where hearing is always easy. The scores are then added standardized from 0 to 100, with lower scores representing a higher frequency of hearing difficulties in the classroom and higher score representing a lower frequency of hearing difficulties. Two versions, the LIFE-R student and the LIFE-R teacher are phrased to apply to the student and the teacher respectively. The LIFE-R Student questionnaire is one of three surveys used to evaluate the primary endpoint: subject-reported quality of life.

Secondary

MeasureTime frameDescription
LIFE-R Teacher6 monthsThe LIFE-R Teacher questionnaire consists of 14 questions that evaluate the student's academic performance, including ability to focus, follow directions, and understand scholastic material when verbally administered. The answers are measured on a scale of 1-5, with 1 indicating a point of constant challenge for the student and 5 indicating no challenge. The scores are then added and standardized from 0 to 100, with lower scores representing a higher frequency of hearing difficulties in the classroom and higher score representing a lower frequency of hearing difficulties. Two versions, the LIFE-R student and the LIFE-R teacher are phrased to apply to the student and the teacher respectively. The LIFE-R Teacher questionnaire was used to evaluate one of the secondary endpoints: classroom performance.
CHILD (Parent) Questionnaire6 monthsThe CHILD (parent) questionnaire consists of 15 questions that describe situations where hearing difficulty may occur when the child is with his/her family. The answers are measured on a scale of 1-8, with 1 indicating poor ability to hear, and 8 indicating complete understanding. The total scores across all questions were standardized on a scale of 0 to 100, with lower scores indicating a worse disease-specific quality of life and higher scores signifying a better disease-specific quality of life. Two versions, the CHILD (child) and the CHILD (parent) are phrased to apply to the child and the parent respectively. The CHILD (parent) survey was used to evaluate one of the study's secondary endpoints: impact of hearing aid with respect to parental perception.

Countries

United States

Participant flow

Recruitment details

A total of 442 children were assessed for eligibility based on presence of mild to moderately-severe UHL and \> 80% word recognition scores. Of these, 325 did not meet eligibility criteria and 80 declined to participate. Thirty-seven children were enrolled from Massachusetts Eye and Ear (n=25), Boston Children's Hospital (n=5), and Cleveland Clinic (n=7) between 2014 and 2019. Thirty-four children completed study interventions. There was no washout period between arms.

Participants by arm

ArmCount
Conventional Measures Only First, Then Conventional Methods + Hearing Aid
Of the participants who completed the study, twenty (20) were assigned to complete the 3-month Conventional Measures Only arm first, during which only FM system and preferential seating were used. After this first 3-month arm, these participants then immediately proceeded to complete the second 3-month Conventional Measures + Hearing Aid arm, during which conventional measures and a hearing aid was used.
20
Conventional Measures + Hearing Aid First, Then Conventional Methods Only
Of the participants who completed the study, fourteen (14) were assigned to complete the 3-month Conventional Measures + Hearing Aid arm first, during which an FM system, preferential seating, and a hearing aid were all used. After this first 3-month arm, these participants then immediately proceeded to complete the second 3-month Conventional Measures Only arm, during which only FM system and preferential seating were used.
14
Total34

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyLost to Follow-up10
Overall StudyWithdrawal by Subject02

Baseline characteristics

CharacteristicConventional Measures + Hearing Aid First, Then Conventional Methods OnlyConventional Measures Only First, Then Conventional Methods + Hearing AidTotal
Age, Categorical
<=18 years
14 Participants20 Participants34 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
0 Participants0 Participants0 Participants
Age, Continuous8.1 years
STANDARD_DEVIATION 1.6
7.9 years
STANDARD_DEVIATION 1.5
8.0 years
STANDARD_DEVIATION 1.5
FM system use prior to trial entry
No
5 Participants7 Participants12 Participants
FM system use prior to trial entry
Unknown
0 Participants1 Participants1 Participants
FM system use prior to trial entry
Yes
9 Participants12 Participants21 Participants
Hearing loss etiology
Acquired
8 Participants13 Participants21 Participants
Hearing loss etiology
Congenital
3 Participants7 Participants10 Participants
Hearing loss etiology
Unknown
3 Participants0 Participants3 Participants
Hearing loss progression
Fluctuating
0 Participants4 Participants4 Participants
Hearing loss progression
Progressive
1 Participants1 Participants2 Participants
Hearing loss progression
Stable
13 Participants15 Participants28 Participants
Hearing loss severity
Mild-moderate (20-60 dB PTA)
11 Participants17 Participants28 Participants
Hearing loss severity
Moderate-severe (60-75 dB PTA)
3 Participants3 Participants6 Participants
Hearing loss type
Conductive
7 Participants13 Participants20 Participants
Hearing loss type
Mixed
1 Participants0 Participants1 Participants
Hearing loss type
Sensorineural
6 Participants7 Participants13 Participants
Race/Ethnicity, Customized
Black
2 Participants0 Participants2 Participants
Race/Ethnicity, Customized
Other/Unknown
1 Participants2 Participants3 Participants
Race/Ethnicity, Customized
White
11 Participants18 Participants29 Participants
Region of Enrollment
United States
14 Participants20 Participants34 Participants
Sex: Female, Male
Female
9 Participants12 Participants21 Participants
Sex: Female, Male
Male
5 Participants8 Participants13 Participants
State and Hospital of Enrollment
Massachusetts (Boston Children's Hospital)
2 Participants2 Participants4 Participants
State and Hospital of Enrollment
Massachusetts (Massachusetts Eye and Ear)
9 Participants14 Participants23 Participants
State and Hospital of Enrollment
Massachusetts Total
11 Participants16 Participants27 Participants
State and Hospital of Enrollment
Ohio (Cleveland Clinic)
3 Participants4 Participants7 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 00 / 0
other
Total, other adverse events
0 / 00 / 0
serious
Total, serious adverse events
0 / 00 / 0

Outcome results

Primary

CHILD (Child) Questionnaires

The CHILD (child) questionnaire consists of 15 questions that describe situations where hearing difficulty may occur when the child is with his/her family. The answers are measured on a scale of 1-8, with 1 indicating poor ability to hear, and 8 indicating complete understanding. The total scores across all questions were standardized on a scale of 0 to 100, with lower scores indicating a worse disease-specific quality of life and higher scores signifying a better disease-specific quality of life. Two versions, the CHILD (child) and the CHILD (parent) are phrased to apply to the child and the parent respectively. The CHILD (child) was one of three surveys used to evaluate the study's primary endpoint: subject-reported quality of life.

Time frame: 6 months

ArmMeasureGroupValue (MEAN)Dispersion
Conventional Methods Only First, Then Conventional Methods + Hearing AidCHILD (Child) QuestionnairesSurvey Round 1 (Arm 1, 0 Weeks)69.21 score on a scaleStandard Deviation 21.55
Conventional Methods Only First, Then Conventional Methods + Hearing AidCHILD (Child) QuestionnairesSurvey Round 2 (Arm 1, 6 Weeks)75.23 score on a scaleStandard Deviation 17.28
Conventional Methods Only First, Then Conventional Methods + Hearing AidCHILD (Child) QuestionnairesSurvey Round 3 (Arm 1, 12 Weeks)77.59 score on a scaleStandard Deviation 13.78
Conventional Methods Only First, Then Conventional Methods + Hearing AidCHILD (Child) QuestionnairesSurvey Round 4 (Arm 2, 12 Weeks)90.36 score on a scaleStandard Deviation 10.55
Conventional Methods Only First, Then Conventional Methods + Hearing AidCHILD (Child) QuestionnairesSurvey Round 5 (Arm 2, 18 Weeks)81.76 score on a scaleStandard Deviation 18.69
Conventional Methods Only First, Then Conventional Methods + Hearing AidCHILD (Child) QuestionnairesSurvey Round 6 (Arm 2, 24 Weeks)88.61 score on a scaleStandard Deviation 11.83
Conventional Methods + Hearing Aid First, Then Conventional Methods OnlyCHILD (Child) QuestionnairesSurvey Round 5 (Arm 2, 18 Weeks)65.42 score on a scaleStandard Deviation 26.41
Conventional Methods + Hearing Aid First, Then Conventional Methods OnlyCHILD (Child) QuestionnairesSurvey Round 1 (Arm 1, 0 Weeks)72.83 score on a scaleStandard Deviation 16.51
Conventional Methods + Hearing Aid First, Then Conventional Methods OnlyCHILD (Child) QuestionnairesSurvey Round 4 (Arm 2, 12 Weeks)67.16 score on a scaleStandard Deviation 20.83
Conventional Methods + Hearing Aid First, Then Conventional Methods OnlyCHILD (Child) QuestionnairesSurvey Round 2 (Arm 1, 6 Weeks)82.83 score on a scaleStandard Deviation 9.64
Conventional Methods + Hearing Aid First, Then Conventional Methods OnlyCHILD (Child) QuestionnairesSurvey Round 6 (Arm 2, 24 Weeks)70.43 score on a scaleStandard Deviation 23.66
Conventional Methods + Hearing Aid First, Then Conventional Methods OnlyCHILD (Child) QuestionnairesSurvey Round 3 (Arm 1, 12 Weeks)80.13 score on a scaleStandard Deviation 14.18
Primary

HEAR-QL 26 Questionnaire

The HEAR-QL consists of 28 items that measure the perceived effect of hearing loss on quality of life. It is adjusted to a scale of 0-100, with lower scores indicating a worse disease-specific quality of life and higher scores signifying a better disease-specific quality of life. The HEAER-QL-26 was one of three surveys used to evaluate the study's primary endpoint: subject-reported quality of life.

Time frame: 6 months

ArmMeasureGroupValue (MEAN)Dispersion
Conventional Methods Only First, Then Conventional Methods + Hearing AidHEAR-QL 26 QuestionnaireSurvey Round 1 (Arm 1, 0 Weeks)69.61 score on a scaleStandard Deviation 15.06
Conventional Methods Only First, Then Conventional Methods + Hearing AidHEAR-QL 26 QuestionnaireSurvey Round 2 (Arm 1, 6 Weeks)71.04 score on a scaleStandard Deviation 18.29
Conventional Methods Only First, Then Conventional Methods + Hearing AidHEAR-QL 26 QuestionnaireSurvey Round 3 (Arm 1, 12 Weeks)74.31 score on a scaleStandard Deviation 20.43
Conventional Methods Only First, Then Conventional Methods + Hearing AidHEAR-QL 26 QuestionnaireSurvey Round 4 (Arm 2, 12 Weeks)77.78 score on a scaleStandard Deviation 26.06
Conventional Methods Only First, Then Conventional Methods + Hearing AidHEAR-QL 26 QuestionnaireSurvey Round 5 (Arm 2, 18 Weeks)79.13 score on a scaleStandard Deviation 21.75
Conventional Methods Only First, Then Conventional Methods + Hearing AidHEAR-QL 26 QuestionnaireSurvey Round 6 (Arm 2, 24 Weeks)80.42 score on a scaleStandard Deviation 23.14
Conventional Methods + Hearing Aid First, Then Conventional Methods OnlyHEAR-QL 26 QuestionnaireSurvey Round 5 (Arm 2, 18 Weeks)73.32 score on a scaleStandard Deviation 24.32
Conventional Methods + Hearing Aid First, Then Conventional Methods OnlyHEAR-QL 26 QuestionnaireSurvey Round 1 (Arm 1, 0 Weeks)74.05 score on a scaleStandard Deviation 15.14
Conventional Methods + Hearing Aid First, Then Conventional Methods OnlyHEAR-QL 26 QuestionnaireSurvey Round 4 (Arm 2, 12 Weeks)76.31 score on a scaleStandard Deviation 22.86
Conventional Methods + Hearing Aid First, Then Conventional Methods OnlyHEAR-QL 26 QuestionnaireSurvey Round 2 (Arm 1, 6 Weeks)80.21 score on a scaleStandard Deviation 16.22
Conventional Methods + Hearing Aid First, Then Conventional Methods OnlyHEAR-QL 26 QuestionnaireSurvey Round 6 (Arm 2, 24 Weeks)75.17 score on a scaleStandard Deviation 23.03
Conventional Methods + Hearing Aid First, Then Conventional Methods OnlyHEAR-QL 26 QuestionnaireSurvey Round 3 (Arm 1, 12 Weeks)87.15 score on a scaleStandard Deviation 10.48
Primary

LIFE-R Student Questionnaires

The LIFE-R Student questionnaire consists of 15 questions that describe situations where hearing difficulty may occur in school. The answers are measured on a scale of 1-5, with 1 indicating situations in which hearing is always difficult and 5 indicating situations where hearing is always easy. The scores are then added standardized from 0 to 100, with lower scores representing a higher frequency of hearing difficulties in the classroom and higher score representing a lower frequency of hearing difficulties. Two versions, the LIFE-R student and the LIFE-R teacher are phrased to apply to the student and the teacher respectively. The LIFE-R Student questionnaire is one of three surveys used to evaluate the primary endpoint: subject-reported quality of life.

Time frame: 6 months

ArmMeasureGroupValue (MEAN)Dispersion
Conventional Methods Only First, Then Conventional Methods + Hearing AidLIFE-R Student QuestionnairesSurvey Round 1 (Arm 1, 0 Weeks)58.83 score on a scaleStandard Deviation 18.86
Conventional Methods Only First, Then Conventional Methods + Hearing AidLIFE-R Student QuestionnairesSurvey Round 2 (Arm 1, 6 Weeks)62.81 score on a scaleStandard Deviation 19.78
Conventional Methods Only First, Then Conventional Methods + Hearing AidLIFE-R Student QuestionnairesSurvey Round 3 (Arm 1, 12 Weeks)64.78 score on a scaleStandard Deviation 17.9
Conventional Methods Only First, Then Conventional Methods + Hearing AidLIFE-R Student QuestionnairesSurvey Round 4 (Arm 2, 12 Weeks)78.76 score on a scaleStandard Deviation 15.15
Conventional Methods Only First, Then Conventional Methods + Hearing AidLIFE-R Student QuestionnairesSurvey Round 5 (Arm 2, 18 Weeks)75.94 score on a scaleStandard Deviation 18.79
Conventional Methods Only First, Then Conventional Methods + Hearing AidLIFE-R Student QuestionnairesSurvey Round 6 (Arm 2, 24 Weeks)80.15 score on a scaleStandard Deviation 16.07
Conventional Methods + Hearing Aid First, Then Conventional Methods OnlyLIFE-R Student QuestionnairesSurvey Round 5 (Arm 2, 18 Weeks)62.22 score on a scaleStandard Deviation 24.09
Conventional Methods + Hearing Aid First, Then Conventional Methods OnlyLIFE-R Student QuestionnairesSurvey Round 1 (Arm 1, 0 Weeks)67.05 score on a scaleStandard Deviation 15.29
Conventional Methods + Hearing Aid First, Then Conventional Methods OnlyLIFE-R Student QuestionnairesSurvey Round 4 (Arm 2, 12 Weeks)63.13 score on a scaleStandard Deviation 23.68
Conventional Methods + Hearing Aid First, Then Conventional Methods OnlyLIFE-R Student QuestionnairesSurvey Round 2 (Arm 1, 6 Weeks)77.05 score on a scaleStandard Deviation 13.25
Conventional Methods + Hearing Aid First, Then Conventional Methods OnlyLIFE-R Student QuestionnairesSurvey Round 6 (Arm 2, 24 Weeks)63.89 score on a scaleStandard Deviation 25
Conventional Methods + Hearing Aid First, Then Conventional Methods OnlyLIFE-R Student QuestionnairesSurvey Round 3 (Arm 1, 12 Weeks)80.37 score on a scaleStandard Deviation 15.18
Secondary

CHILD (Parent) Questionnaire

The CHILD (parent) questionnaire consists of 15 questions that describe situations where hearing difficulty may occur when the child is with his/her family. The answers are measured on a scale of 1-8, with 1 indicating poor ability to hear, and 8 indicating complete understanding. The total scores across all questions were standardized on a scale of 0 to 100, with lower scores indicating a worse disease-specific quality of life and higher scores signifying a better disease-specific quality of life. Two versions, the CHILD (child) and the CHILD (parent) are phrased to apply to the child and the parent respectively. The CHILD (parent) survey was used to evaluate one of the study's secondary endpoints: impact of hearing aid with respect to parental perception.

Time frame: 6 months

ArmMeasureGroupValue (MEAN)Dispersion
Conventional Methods Only First, Then Conventional Methods + Hearing AidCHILD (Parent) QuestionnaireSurvey Round 4 (Arm 2, 12 Weeks)91.24 score on a scaleStandard Deviation 5.78
Conventional Methods Only First, Then Conventional Methods + Hearing AidCHILD (Parent) QuestionnaireSurvey Round 1 (Arm 1, 0 Weeks)68.52 score on a scaleStandard Deviation 19.57
Conventional Methods Only First, Then Conventional Methods + Hearing AidCHILD (Parent) QuestionnaireSurvey Round 5 (Arm 2, 18 Weeks)85.93 score on a scaleStandard Deviation 15.31
Conventional Methods Only First, Then Conventional Methods + Hearing AidCHILD (Parent) QuestionnaireSurvey Round 3 (Arm 1, 12 Weeks)72.77 score on a scaleStandard Deviation 16.7
Conventional Methods Only First, Then Conventional Methods + Hearing AidCHILD (Parent) QuestionnaireSurvey Round 6 (Arm 2, 24 Weeks)84.27 score on a scaleStandard Deviation 14.47
Conventional Methods Only First, Then Conventional Methods + Hearing AidCHILD (Parent) QuestionnaireSurvey Round 2 (Arm 1, 6 Weeks)67.24 score on a scaleStandard Deviation 13.52
Conventional Methods + Hearing Aid First, Then Conventional Methods OnlyCHILD (Parent) QuestionnaireSurvey Round 6 (Arm 2, 24 Weeks)63.10 score on a scaleStandard Deviation 23.81
Conventional Methods + Hearing Aid First, Then Conventional Methods OnlyCHILD (Parent) QuestionnaireSurvey Round 2 (Arm 1, 6 Weeks)81.81 score on a scaleStandard Deviation 10.29
Conventional Methods + Hearing Aid First, Then Conventional Methods OnlyCHILD (Parent) QuestionnaireSurvey Round 3 (Arm 1, 12 Weeks)81.73 score on a scaleStandard Deviation 12.79
Conventional Methods + Hearing Aid First, Then Conventional Methods OnlyCHILD (Parent) QuestionnaireSurvey Round 4 (Arm 2, 12 Weeks)64.19 score on a scaleStandard Deviation 19.93
Conventional Methods + Hearing Aid First, Then Conventional Methods OnlyCHILD (Parent) QuestionnaireSurvey Round 5 (Arm 2, 18 Weeks)68.13 score on a scaleStandard Deviation 26.41
Conventional Methods + Hearing Aid First, Then Conventional Methods OnlyCHILD (Parent) QuestionnaireSurvey Round 1 (Arm 1, 0 Weeks)73.40 score on a scaleStandard Deviation 12.96
Secondary

LIFE-R Teacher

The LIFE-R Teacher questionnaire consists of 14 questions that evaluate the student's academic performance, including ability to focus, follow directions, and understand scholastic material when verbally administered. The answers are measured on a scale of 1-5, with 1 indicating a point of constant challenge for the student and 5 indicating no challenge. The scores are then added and standardized from 0 to 100, with lower scores representing a higher frequency of hearing difficulties in the classroom and higher score representing a lower frequency of hearing difficulties. Two versions, the LIFE-R student and the LIFE-R teacher are phrased to apply to the student and the teacher respectively. The LIFE-R Teacher questionnaire was used to evaluate one of the secondary endpoints: classroom performance.

Time frame: 6 months

ArmMeasureGroupValue (MEAN)Dispersion
Conventional Methods Only First, Then Conventional Methods + Hearing AidLIFE-R TeacherSurvey Round 1 (Arm 1, 0 Weeks)68.69 score on a scaleStandard Deviation 20.8
Conventional Methods Only First, Then Conventional Methods + Hearing AidLIFE-R TeacherSurvey Round 2 (Arm 1, 6 Weeks)73.66 score on a scaleStandard Deviation 19.55
Conventional Methods Only First, Then Conventional Methods + Hearing AidLIFE-R TeacherSurvey Round 3 (Arm 1, 12 Weeks)74.26 score on a scaleStandard Deviation 17.63
Conventional Methods Only First, Then Conventional Methods + Hearing AidLIFE-R TeacherSurvey Round 4 (Arm 2, 12 Weeks)75.74 score on a scaleStandard Deviation 19.47
Conventional Methods Only First, Then Conventional Methods + Hearing AidLIFE-R TeacherSurvey Round 5 (Arm 2, 18 Weeks)83.31 score on a scaleStandard Deviation 17.81
Conventional Methods Only First, Then Conventional Methods + Hearing AidLIFE-R TeacherSurvey Round 6 (Arm 2, 24 Weeks)83.94 score on a scaleStandard Deviation 16.08
Conventional Methods + Hearing Aid First, Then Conventional Methods OnlyLIFE-R TeacherSurvey Round 5 (Arm 2, 18 Weeks)78.08 score on a scaleStandard Deviation 19.96
Conventional Methods + Hearing Aid First, Then Conventional Methods OnlyLIFE-R TeacherSurvey Round 1 (Arm 1, 0 Weeks)83.55 score on a scaleStandard Deviation 11
Conventional Methods + Hearing Aid First, Then Conventional Methods OnlyLIFE-R TeacherSurvey Round 4 (Arm 2, 12 Weeks)79.57 score on a scaleStandard Deviation 15.54
Conventional Methods + Hearing Aid First, Then Conventional Methods OnlyLIFE-R TeacherSurvey Round 2 (Arm 1, 6 Weeks)90.61 score on a scaleStandard Deviation 6.82
Conventional Methods + Hearing Aid First, Then Conventional Methods OnlyLIFE-R TeacherSurvey Round 6 (Arm 2, 24 Weeks)83.27 score on a scaleStandard Deviation 16.73
Conventional Methods + Hearing Aid First, Then Conventional Methods OnlyLIFE-R TeacherSurvey Round 3 (Arm 1, 12 Weeks)89.77 score on a scaleStandard Deviation 9.74

Source: ClinicalTrials.gov · Data processed: Feb 25, 2026