Evaluation of a Digital Handheld Hydrogen Breath Monitor to Diagnose Lactose Malabsorption: Interventional Crossover Study.

BACKGROUND: Lactose malabsorption is a common condition that affects a broad segment of the population. Clinical diagnosis based on symptom recall can be unreliable and conventional testing can be inconvenient, requiring expensive laboratory-based equipment and conduction of the testing in a clinical setting. OBJECTIVE: The aim of this study is to assess the performance of a digital handheld hydrogen breath monitor (GIMate) in diagnosing lactose malabsorption compared to a US Food and Drug Administration (FDA)-cleared device (H2 Check) for the same indication. METHODS: An interventional crossover study was performed in adult participants with a prior confirmed diagnosis of lactose malabsorption or a suspected history of lactose intolerance. RESULTS: A total of 31 participants (mean age 33.9 years) were enrolled in the study. There was 100% positive percent agreement and 100% negative percent agreement between the GIMate monitor and the H2 Check. Correlation between gastrointestinal symptoms and hydrogen values was positive at 0.82 (P<.001). CONCLUSIONS: The digital handheld GIMate breath monitor achieved equivalent diagnostic performance to that of an FDA-cleared device in the diagnosis of lactose malabsorption. TRIAL REGISTRATION: ClinicalTrials.gov NCT04754724; https://clinicaltrials.gov/ct2/show/NCT04754724.

The MED-EL SONATATI 100 cochlear implant: an evaluation of its safety in adults and children.

CONCLUSIONS: Data from 50 patients suggest that the SONATATI(100) cochlear implant (CI) is a safe and effective device. OBJECTIVE: MED-EL has developed and tested a CI with titanium housing (the SONATATI(100)), which has the same internal components as the PULSARCI(100). Implant surgery should be less traumatic, as with these CIs smaller incisions and less drilling are involved. The study aimed to assess surgical issues pertaining to the implantation of the device, patient compatibility with the titanium of the implant housing, and other patient-related issues. METHODS: Fifty patients were recruited into this multicenter study. In phase 1, 30 adults and in phase 2, 20 children received a SONATATI(100) cochlear implant. An intraoperative survey was completed by the surgeons for all patients. A postoperative survey was completed by the audiologists/fitting engineers at first fitting and 3 and 6 months after the first fitting to evaluate the safety and the efficacy of the device. RESULTS: The device was proven to be effective in that it was stable in the implant bed and that minimally invasive surgery could be carried out. The device was proven to be safe after medium-term use and no unexpected adverse events were reported.

Causes of hearing impairment in the Norwegian paediatric cochlear implant program.

Severe to profound hearing impairment (HI) is estimated to affect around 1/2000 young children. Advances in genetics have made it possible to identify several genes related to HI. This information can cast light upon prognostic factors regarding the outcome in cochlear implantation, and provide information both for scientific and genetic counselling purposes. From 1992 to 2005, 273 children from 254 families (probands) were offered cochlear implants in Norway. An evaluation of the causes of HI, especially regarding the genes GJB2, GJB6, SLC26A4, KCNQ1, KCNE1, and the mutation A1555G in mitochondrial DNA was performed in 85% of the families. The number of probands with unknown cause of HI was thus reduced from 120 to 68 (43% reduction). Ninety-eight (46%) of the probands had an identified genetic etiology of their HI. A relatively high prevalence of Jervell and Lange-Nielsen syndrome was found. The main causes of severe and profound HI were similar to those found in other European countries. GJB2 mutations are a common cause of prelingual HI in Norwegian cochlear implanted children.

Jervell and Lange-Nielsen syndrome in Norwegian children: aspects around cochlear implantation, hearing, and balance.

OBJECTIVES: Jervell and Lange-Nielsen syndrome (JLNS) is a rare cause of autosomal recessive inherited deafness. JLNS patients are candidates for cochlear implantation, and represent a group that needs special attention and precautions. The aim of this article is to draw some guidelines for dealing with these patients, and to emphasize the importance of electrocardiography (ECG) screening of congenitally deaf patients. A probable vestibular dysfunction is also discussed. DESIGN: Eight of 273 implanted children (2.9%) at Rikshospitalet-Radiumhospitalet Medical Center, Oslo, Norway have been diagnosed with JLNS. All the children were evaluated with ECG, six of them before cochlear implantation. Auditory perception was evaluated with the littlEARS Auditory Questionnaire, or with a test battery developed at Rikshospitalet-Radiumhospitalet Medical Center. DNA sequencing was used to screen for mutations in the genes KCNQ1 and KCNE1. The cases are presented and discussed in a retrospective case review. RESULTS: Two of the children are dead. The corrected QT (QTc) interval in the ECG was markedly prolonged in all the children (median QTc, 0.59 sec; range, 0.53-0.65). Six children have more than 1 yr experience with their cochlear implant. Four of them are performing average or above compared with the other implanted children. All the children have mutations in the KCNQ1 gene. Six of our patients have delayed gross motor development, and the remaining two are markedly delayed compared with their older siblings. CONCLUSIONS: Cochlear implantation can be performed safely and with good results in children with JLNS, but requires knowledge of the diagnosis and necessary precautions have to be taken. ECG should be taken for all children with congenital deafness, preferably before exposure to strong sound stimuli. Vestibular dysfunction seems to be a part of JLNS, but this needs further investigation.

Cochlear implants and quality of life: a prospective study.

OBJECTIVE: To evaluate changes in quality of life, anxiety, and depression after cochlear implantation in adults. DESIGN: Twenty-seven postlingually deafened adults who had received a MED-EL Combi 40+ implant were investigated. One generic Health-Related Quality of Life measure, the SF-36, two disease-specific measures, the Patient Quality of Life Form (PQLF) and the Index Relative Questionnaire Form (IRQF) completed by a near relative to the patient, in addition to a domain specific measure, the Hopkins Symptom Check List 25 items (HSCL-25), were used in a prospective study. The subjects were investigated before surgery and 12 to 15 months after surgery. RESULTS: The scores were significantly better after surgery in four of six categories of the PQLF. In the IRQF, where a family member of the cochlear implant recipient was studied, the scores were significantly better in four of five categories. There was a significant improvement in the HSCL-25 scores after surgery. In the SF-36, only one of eight scales showed significant improvement. CONCLUSIONS: Cochlear implants were associated with statistically significant improvement in quality of life in postlingually deafened adults. The improvements were largest in the categories concerning communication, feelings of being a burden, isolation, and relations to friends and family. The implants also improved the relatives' daily lives. There was a statistically significant reduction in degree of depression and anxiety. Reduction in anxiety and depression was associated with gain in quality of life.

Cochlear implants and health status: a comparison with other hearing-impaired patients.

Eighty-four adult cochlear implant (CI) users were compared with 3 other groups of severely to profoundly hearing impaired adults concerning quality of life (QOL): 1) 19 CI candidates who were accepted as candidates for implantation, but who were not operated on; 2) 16 CI candidates whose impairment was not severe enough for implantation; and 3) 60 users of acoustic hearing aids. Generic and disease-specific QOL questionnaires were used. The CI group scored significantly better than the CI candidates who met the criteria for implantation, but who were not operated on, on 2 of 6 categories of a disease-specific QOL measure. The CI patients had significantly less anxiety and depression than the unoperated CI candidates who met the criteria for implantation. Validation and reliability testing of 2 disease-specific QOL measures were performed by factor analyses.

Social hearing measured with the Performance Inventory for Profound and Severe Loss: a comparison between adult multichannel cochlear implant patients and users of acoustical hearing aids.

The objective of this study was to investigate social hearing in successful users of multichannel cochlear implants (CIs) and to compare the scores with those of a group of hearing-impaired adults using acoustical hearing aids (HAs). Out of 88 patients who had undergone surgery, 75 CI users with a mean age of 55 years and a mean pre-operative hearing level of 113dB in the better ear were compared with 59 users of acoustical HAs with a mean age of 56 years and a mean hearing level of 82dB in the better ear. Seven CI patients were non-users and were excluded from the study. The Performance Inventory for Profound and Severe Loss, a questionnaire that measures different aspects of hearing handicap, was used. The CI group scored significantly better than the HA group in three of six evaluated categories, measuring subjective intensity of sounds, speech with visual cues, and response to auditory failure. Awareness of environmental sounds, speech with no visual cues and personal reactions did not differ significantly. The group of successful CI users scored higher on a self-report measure than did a group of users of acoustical HAs with moderate- severe-profound deafness. The best CI users scored better than the best HA users, and the worst CI users scored worse than the worst HA users.

Tinnitus in cochlear implant patients--a comparison with other hearing-impaired patients.

As part of a quality of life study, 84 patients who received multichannel intra-cochlear cochlear implants (CIs) were evaluated regarding tinnitus problems by a questionnaire. As controls, 60 hearing aid (HA) users and 35 non-operated CI candidates were used. The prevalence of tinnitus in the CI group was 70%, and that of troublesome tinnitus was 35%. In the two other groups, the prevalences of tinnitus were 40% (HA) and 74% (non-CI). Twenty-three per cent of HA users and 51% of non-operated CI candidates had troublesome tinnitus. CIs were found to be superior to HAs in reducing tinnitus, 54% of the CI patients with tinnitus experiencing a reduction in tinnitus when using a CI. In the other two groups, 4% of HA users and 23% of non-operated CI candidates experienced a reduction in tinnitus when using an HA. Eight per cent of the CI patients with tinnitus experienced an increase in tinnitus when using their implant. Not having paid employment was independently associated with troublesome tinnitus in all three groups.